Trial Outcomes & Findings for A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis (NCT NCT03393013)

Last Updated: 2025-11-18

Results Overview

The safety and tolerability of zetomipzomib (KZR-616) when administered as a subcutaneous injection weekly for 13 weeks in adult patients with systemic lupus erythematous (SLE) with and without nephritis, as assessed by number of patients who experienced at least one treatment-related treatment-emergent adverse event. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

69 participants

Primary outcome timeframe

25 weeks

Results posted on

2025-11-18

Participant Flow

Patients who were enrolled in Phase 1b were ineligible to enroll in the Phase 2 portion of the study.

Participant milestones

Participant milestones
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	KZR-616 QW, 60 mg + SOC (Phase 2) KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg). 60 mg dose level of KZR-616 selected based on data from the Phase 1b dose escalation and administered to patients with active lupus nephritis in combination with SOC therapy including at least one immunosuppressive agent. KZR-616: Subcutaneous Injection of KZR-616 \*See Limitations/Caveats for additional information
Phase 1b STARTED	8	5	14	6	8	6	0
Phase 1b COMPLETED	5	2	10	6	8	4	0
Phase 1b NOT COMPLETED	3	3	4	0	0	2	0
Phase 2 STARTED	0	0	0	0	0	0	22
Phase 2 COMPLETED	0	0	0	0	0	0	18
Phase 2 NOT COMPLETED	0	0	0	0	0	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline metric was measured for all patients in Phase 2. For Phase 1b, only two patients had active lupus nephritis with significant proteinuria.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=8 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=5 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=14 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=6 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=8 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) n=6 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	KZR-616 QW, 60 mg + SOC (Phase 2) n=22 Participants KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg). 60 mg dose level of KZR-616 selected based on data from the Phase 1b dose escalation and administered to patients with active lupus nephritis in combination with SOC therapy including at least one immunosuppressive agent. KZR-616: Subcutaneous Injection of KZR-616 \*See Limitations/Caveats for additional information	Total n=69 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 11.5 • n=8 Participants	46.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.6 years STANDARD_DEVIATION 15.3 • n=14 Participants	54.3 years STANDARD_DEVIATION 14.8 • n=6 Participants	48.1 years STANDARD_DEVIATION 10.3 • n=8 Participants	45.0 years STANDARD_DEVIATION 17.5 • n=6 Participants	34.6 years STANDARD_DEVIATION 11.7 • n=22 Participants	45.5 years STANDARD_DEVIATION 14.9 • n=69 Participants
Sex: Female, Male Female	8 Participants n=8 Participants	5 Participants n=5 Participants	12 Participants n=14 Participants	6 Participants n=6 Participants	8 Participants n=8 Participants	6 Participants n=6 Participants	20 Participants n=22 Participants	65 Participants n=69 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	0 Participants n=5 Participants	2 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	2 Participants n=22 Participants	4 Participants n=69 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=8 Participants	3 Participants n=5 Participants	10 Participants n=14 Participants	2 Participants n=6 Participants	5 Participants n=8 Participants	3 Participants n=6 Participants	12 Participants n=22 Participants	39 Participants n=69 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=8 Participants	2 Participants n=5 Participants	4 Participants n=14 Participants	4 Participants n=6 Participants	3 Participants n=8 Participants	3 Participants n=6 Participants	10 Participants n=22 Participants	30 Participants n=69 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=22 Participants	0 Participants n=69 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	4 Participants n=22 Participants	4 Participants n=69 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=5 Participants	1 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=22 Participants	2 Participants n=69 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=22 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants	2 Participants n=5 Participants	1 Participants n=14 Participants	2 Participants n=6 Participants	1 Participants n=8 Participants	3 Participants n=6 Participants	1 Participants n=22 Participants	11 Participants n=69 Participants
Race (NIH/OMB) White	7 Participants n=8 Participants	3 Participants n=5 Participants	12 Participants n=14 Participants	4 Participants n=6 Participants	7 Participants n=8 Participants	3 Participants n=6 Participants	7 Participants n=22 Participants	43 Participants n=69 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=22 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	9 Participants n=22 Participants	9 Participants n=69 Participants
UPCR at Baseline	—	—	3.85 mg/mg n=1 Participants • This baseline metric was measured for all patients in Phase 2. For Phase 1b, only two patients had active lupus nephritis with significant proteinuria.	—	2.39 mg/mg n=1 Participants • This baseline metric was measured for all patients in Phase 2. For Phase 1b, only two patients had active lupus nephritis with significant proteinuria.	—	2.50 mg/mg STANDARD_DEVIATION 2.56 • n=22 Participants • This baseline metric was measured for all patients in Phase 2. For Phase 1b, only two patients had active lupus nephritis with significant proteinuria.	2.55 mg/mg STANDARD_DEVIATION 2.46 • n=24 Participants • This baseline metric was measured for all patients in Phase 2. For Phase 1b, only two patients had active lupus nephritis with significant proteinuria.
eGFR Level at Baseline	—	—	—	—	—	—	104.71 mL/min/1.73 m^2 STANDARD_DEVIATION 32.579 • n=21 Participants • This baseline metric was only measured for patients in Phase 2. Additionally, this baseline metric is not available for one patient from Phase 2 who was enrolled in an earlier protocol amendment. \\ See Limitations/Caveat Section	104.71 mL/min/1.73 m^2 STANDARD_DEVIATION 32.579 • n=21 Participants • This baseline metric was only measured for patients in Phase 2. Additionally, this baseline metric is not available for one patient from Phase 2 who was enrolled in an earlier protocol amendment. \\ See Limitations/Caveat Section

PRIMARY outcome

Timeframe: 25 weeks

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=8 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=5 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=14 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=6 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=8 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) n=6 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 1b: Number of Patients Who Experienced at Least One Treatment-Related Treatment-Emergent Adverse Event	7 Participants	5 Participants	11 Participants	3 Participants	6 Participants	3 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Outcome only measured for Phase 2. One patient is excluded (N=21) due to enrollment under an earlier Protocol Amendment. Prior to the open-label design, 1 patient was enrolled in Phase 2. Efficacy data for this patient are not included in this analysis because the patient received zetomipzomib for a shorter time duration (13 weeks) than specified by the outcome measure. \*See Limitations and Caveats section for more information

To assess the number of patients with lupus nephritis with a 50% reduction in UPCR after 24 weeks of weekly SC injections with KZR-616 when compared to baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=21 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 2: Number of Patients With Lupus Nephritis With a 50% Reduction in UPCR	11 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 8 hours

Population: This outcome was only measured in Phase 1b. The PK population is different than the overall studied population. As is pre-specified in the study protocol, analysis was completed per dose/treatment instead of per cohort for PK data.

This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=1 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=9 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=20 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=4 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 1b: PK of KZR-616 (Cmax)	74.2 ng/mL	134 ng/mL Geometric Coefficient of Variation 45.6	151 ng/mL Geometric Coefficient of Variation 50.3	265 ng/mL Geometric Coefficient of Variation 60.4	—	—

SECONDARY outcome

Timeframe: 8 hours

This is the time to maximum observed plasma concentration (tmax) observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=1 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=9 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=20 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=4 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 1b: PK of KZR-616 (Tmax)	1.00 hours	0.25 hours Interval 0.13 to 1.0	0.25 hours Interval 0.08 to 2.0	0.50 hours Interval 0.25 to 0.52	—	—

SECONDARY outcome

Timeframe: 8 hours

This is the area under the curve (AUC) from predose through 8 hour postdose observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=1 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=8 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=19 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=4 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 1b: PK of KZR-616 (AUC)	258 ng*h/ml	387 ng*h/ml Geometric Coefficient of Variation 38.1	430 ng*h/ml Geometric Coefficient of Variation 36.8	636 ng*h/ml Geometric Coefficient of Variation 31.7	—	—

SECONDARY outcome

Timeframe: 24 weeks

Number of patients with a partial renal response (PRR) after 24 weeks of treatment, as defined by: 1. For this outcome measure, Primary UPCR criterion was used (a 50% reduction of UPCR and reduction of UPCR to \<1.0 if baseline UPCR was \<3.0 (or reduction of UPCR to \<3.0 if baseline was ≥3.0)) 2. eGFR of greater than or equal to 60 mL/min/1.73 m\^2 or no worsening of eGFR from baseline of greater than or equal to 25% 3. No use of prohibited medication Count of patients below includes those who satisfy all three of the above criteria.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=21 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 2: Number of Patients With a Partial Renal Response	10 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 37 weeks

Population: This outcome measure was only analyzed for Phase 2.

Exposure adjusted adverse event incidence rate for Injection Site Reactions and Systemic Injection Reactions. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=447 Number of exposures Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 2: Safety and Tolerability of KZR-616 When Administered as a SC Injection Weekly for 24 Weeks Injection Site Reactions	0.036 events per person-weeks	—	—	—	—	—
Phase 2: Safety and Tolerability of KZR-616 When Administered as a SC Injection Weekly for 24 Weeks Systemic Injection Reactions	0.045 events per person-weeks	—	—	—	—	—

SECONDARY outcome

Timeframe: 25 weeks

Population: The DMC reviewed cumulative Phase 1b study data and provided a recommendation for the Phase 2 dose.

The safety data from Phase 1b were used to determine a recommended dose of zetomipzomib to administer to patients with active proliferative lupus nephritis in Phase 2 of this study. As pre-specified in the study protocol, this outcome measure was to be determined qualitatively through discussion of relevant information from the Phase 1b portion of the trial at a data monitoring committee meeting.

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=47 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 1b: Recommended Phase 2 Doses of Zetomipzomib When Administered as a Subcutaneous Injection	60 mg	—	—	—	—	—

POST_HOC outcome

Timeframe: Week 25

Population: Only two patients in the Phase 1b study had active lupus nephritis.

Changes in lupus disease assessments and changes from baseline in laboratory measures \- Renal parameters (UPCR) in Patients with SLE who had active lupus nephritis at baseline, 13 weeks (end of treatment), and 25 weeks (end of study)

Outcome measures

Outcome measures
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=1 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=1 Participants Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616
Phase 1b: Changes in UPCR in Patients With SLE Who Had Active Lupus Nephritis Baseline	3.85 g/g	2.39 g/g	—	—	—	—
Phase 1b: Changes in UPCR in Patients With SLE Who Had Active Lupus Nephritis Week 13 (End of Treatment)	2.89 g/g	0.69 g/g	—	—	—	—
Phase 1b: Changes in UPCR in Patients With SLE Who Had Active Lupus Nephritis Week 25 (End of Study)	1.12 g/g	1.47 g/g	—	—	—	—

Adverse Events

Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b)

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

KZR-616 QW, 60 mg + SOC (Phase 2)

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=8 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=5 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=14 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=6 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=8 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) n=6 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	KZR-616 QW, 60 mg + SOC (Phase 2) n=22 participants at risk KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg). 60 mg dose level of KZR-616 selected based on data from the Phase 1b dose escalation and administered to patients with active lupus nephritis in combination with SOC therapy including at least one immunosuppressive agent. KZR-616: Subcutaneous Injection of KZR-616 \*See Limitations/Caveats for additional information
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Systemic inflammatory response syndrome	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Herpes zoster	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Urinary tract infection	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Viral infection	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Migraine	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.

Other adverse events

Other adverse events
Measure	Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) n=8 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) n=5 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) n=14 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=6 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) n=8 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses. KZR-616: Subcutaneous Injection of KZR-616	Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) n=6 participants at risk Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy. KZR-616: Subcutaneous Injection of KZR-616	KZR-616 QW, 60 mg + SOC (Phase 2) n=22 participants at risk KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg). 60 mg dose level of KZR-616 selected based on data from the Phase 1b dose escalation and administered to patients with active lupus nephritis in combination with SOC therapy including at least one immunosuppressive agent. KZR-616: Subcutaneous Injection of KZR-616 \*See Limitations/Caveats for additional information
Eye disorders Dry eye	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Eye disorders Eyelid oedema	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Cardiac disorders Tachycardia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Ear and labyrinth disorders Ear pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Eye disorders Cataract nuclear	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Eye disorders Conjunctival haemorrhage	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Eye disorders Periorbital oedema	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Eye disorders Photophobia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Eye disorders Scleritis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	33.3% 2/6 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Acid peptic disease	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 7 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	22.7% 5/22 • Number of events 7 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Lip swelling	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Lip ulceration	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Mouth ulceration	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	80.0% 4/5 • Number of events 6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	35.7% 5/14 • Number of events 8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	50.0% 4/8 • Number of events 24 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	50.0% 3/6 • Number of events 10 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.9% 9/22 • Number of events 22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Odynophagia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Oral pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	100.0% 5/5 • Number of events 7 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	21.4% 3/14 • Number of events 6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.9% 9/22 • Number of events 14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Asthenia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	22.7% 5/22 • Number of events 10 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Chest pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Fatigue	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 13 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 19 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Chills	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 4 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	18.2% 4/22 • Number of events 9 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Feeling cold	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Generalised oedema	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Influenza like illness	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site bruising	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	14.3% 2/14 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 16 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site discolouration	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 10 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 4 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site erythema	62.5% 5/8 • Number of events 30 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.0% 2/5 • Number of events 7 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	35.7% 5/14 • Number of events 16 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	33.3% 2/6 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	75.0% 6/8 • Number of events 58 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	54.5% 12/22 • Number of events 66 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site extravasation	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site haemorrhage	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site indentation	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site induration	12.5% 1/8 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.0% 2/5 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 12 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	22.7% 5/22 • Number of events 28 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site mass	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	18.2% 4/22 • Number of events 40 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site nodule	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	14.3% 2/14 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	28.6% 4/14 • Number of events 11 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	27.3% 6/22 • Number of events 30 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site pruritus	25.0% 2/8 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site rash	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site reaction	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Injection site swelling	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	14.3% 2/14 • Number of events 7 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	18.2% 4/22 • Number of events 31 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Oedema peripheral	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	33.3% 2/6 • Number of events 4 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Peripheral swelling	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Puncture site pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Pyrexia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.0% 2/5 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	21.4% 3/14 • Number of events 10 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	50.0% 3/6 • Number of events 5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	59.1% 13/22 • Number of events 45 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Swelling	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
General disorders Thirst	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Immune system disorders Selective IgG subclass deficiency	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Bacterial vaginosis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Body tinea	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Bronchitis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Clostridium difficile infection	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Conjunctivitis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Corona virus infection	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Herpes zoster	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Hordeolum	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Laryngitis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Nasopharyngitis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Oral candidiasis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Otitis externa	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Pharyngitis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Pyelonephritis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Skin candida	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Injury, poisoning and procedural complications Chest injury	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Injury, poisoning and procedural complications Post vaccination syndrome	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 16 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Injury, poisoning and procedural complications Thermal burn	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Amylase increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Blood creatine phosphokinase increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Blood triglycerides increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Body temperature increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 41 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Differential white blood cell count abnormal	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Electrocardiogram PR prolongation	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Electrocardiogram abnormal	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Gamma-glutamyltransferase increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Lipase increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Protein urine present	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations Reticulocyte count increased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Investigations White blood cell count decreased	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 9 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 9 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 10 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	22.7% 5/22 • Number of events 8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Chondritis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	37.5% 3/8 • Number of events 12 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Musculoskeletal and connective tissue disorders Rib deformity	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.0% 2/5 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	40.0% 2/5 • Number of events 13 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	21.4% 3/14 • Number of events 9 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	50.0% 3/6 • Number of events 11 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	50.0% 11/22 • Number of events 32 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Lethargy	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Migraine	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Migraine with aura	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Paraesthesia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Post herpetic neuralgia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Nervous system disorders Somnolence	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Psychiatric disorders Depression	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Psychiatric disorders Insomnia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Psychiatric disorders Mental status changes	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Reproductive system and breast disorders Pelvic cyst	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	16.7% 1/6 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Blister	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Lipohypertrophy	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	12.5% 1/8 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 9 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	13.6% 3/22 • Number of events 9 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	20.0% 1/5 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 4 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/14 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	25.0% 2/8 • Number of events 3 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Vascular disorders Hot flush	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/22 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Vascular disorders Hypertension	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	4.5% 1/22 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
Vascular disorders Hypotension	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/5 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	7.1% 1/14 • Number of events 1 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/8 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	0.00% 0/6 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.	9.1% 2/22 • Number of events 2 • The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively. Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.

Additional Information

Regulatory Affairs

Kezar Life Sciences, Inc

Phone: 650-822-5600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI shall have the right to publish or present their own data resulting from the Study ("Publication") upon the earlier of: (a) the date following a multicenter publication coordinated by Sponsor regarding the Protocol; (b) 12 months after completion of the Protocol by all sites; or (c) the date after submission of the Study Data by Sponsor to the FDA. The PI must furnish Sponsor with a copy of any Publication at least 30 days in advance of the proposed submission or presentation date.
Publication restrictions are in place

Restriction type: OTHER