Trial Outcomes & Findings for Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease (NCT NCT03403205)

Last Updated: 2024-06-17

Results Overview

dNCC is the directly quantified copper not bound to ceruloplasmin, obtained by inductively coupled plasma mass spectrometry after immunocapture and removal of ceruloplasmin. Baseline was defined as last non-missing value on or before first study drug administration. Least square (LS) mean and standard error (SE) was calculated using analysis of covariance (ANCOVA).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

214 participants

Primary outcome timeframe

Baseline to Week 48

Results posted on

2024-06-17

Participant Flow

The study consisted of 2 periods: Primary Evaluation Period (PEP) and Open-label Extension (OLE) Period. Participants who completed the 48-week PEP were offered the opportunity to continue treatment in an up to 60-month Extension. A total of 214 participants were randomized; 207 participants were treated in the PEP.

Participants were randomized, stratified by cohort, in a 2:1 ratio to treatment with ALXN1840 or continued treatment with Standard of Care (SoC). Two cohorts were defined. Cohort 1: participants previously treated with SoC for \>28 days; Cohort 2: participants who were treatment naïve or previously treated with SoC for ≤28 days. Participants who completed participation in Study WTX101-201 (NCT02273596) were offered the opportunity to participate in the Study WTX101-301 OLE Period.

Participant milestones

Participant milestones
Measure	Cohort 1: ALXN1840 Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 1: WTX101-201- ALXN1840 Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months in the OLE period of this study.	Cohort 2: WTX101-201- ALXN1840 Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months in the OLE period of this study.
Primary Evaluation Period (48 Weeks) STARTED	105	56	37	16	0	0
Primary Evaluation Period (48 Weeks) Received at Least 1 Dose of Study Drug	104	56	33	14	0	0
Primary Evaluation Period (48 Weeks) Completed PEP, Enter Extension	89	49	28	12	0	0
Primary Evaluation Period (48 Weeks) Completed PEP, Not Into Extension	4	3	1	1	0	0
Primary Evaluation Period (48 Weeks) COMPLETED	93	52	29	13	0	0
Primary Evaluation Period (48 Weeks) NOT COMPLETED	12	4	8	3	0	0
Extension Period (Up to 60 Months) STARTED	89	49	28	12	8	11
Extension Period (Up to 60 Months) COMPLETED	0	0	0	0	0	1
Extension Period (Up to 60 Months) NOT COMPLETED	89	49	28	12	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: ALXN1840 Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 1: WTX101-201- ALXN1840 Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months in the OLE period of this study.	Cohort 2: WTX101-201- ALXN1840 Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months in the OLE period of this study.
Primary Evaluation Period (48 Weeks) Withdrawal by Subject	4	2	2	1	0	0
Primary Evaluation Period (48 Weeks) Adverse Event	4	0	1	0	0	0
Primary Evaluation Period (48 Weeks) Death	1	0	1	0	0	0
Primary Evaluation Period (48 Weeks) Lost to Follow-up	1	1	0	0	0	0
Primary Evaluation Period (48 Weeks) Pregnancy	1	0	0	0	0	0
Primary Evaluation Period (48 Weeks) Protocol Deviation	0	1	0	0	0	0
Primary Evaluation Period (48 Weeks) Randomized but not treated	1	0	4	2	0	0
Extension Period (Up to 60 Months) Withdrawal by Subject	6	7	2	1	0	2
Extension Period (Up to 60 Months) Adverse Event	6	3	1	1	0	0
Extension Period (Up to 60 Months) Death	1	0	0	0	0	0
Extension Period (Up to 60 Months) Lost to Follow-up	1	0	0	0	0	0
Extension Period (Up to 60 Months) Pregnancy	1	1	0	0	0	0
Extension Period (Up to 60 Months) Protocol Deviation	1	0	0	0	0	0
Extension Period (Up to 60 Months) Study Terminated by Sponsor	66	32	21	10	7	8
Extension Period (Up to 60 Months) Other than specified	5	5	3	0	1	0
Extension Period (Up to 60 Months) Physician Decision	2	1	1	0	0	0

Baseline Characteristics

Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: ALXN1840 n=104 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks.	Cohort 1: SoC Therapy n=56 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy for up to 48 weeks according to the local package label.	Cohort 2: ALXN1840 n=33 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks.	Cohort 2: SoC Therapy n=14 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received/continued to receive SoC therapy for up to 48 weeks according to the local package label.	Cohort 1: WTX101-201- ALXN1840 n=8 Participants Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months.	Cohort 2: WTX101-201- ALXN1840 n=11 Participants Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months.	Total n=226 Participants Total of all reporting groups
Age, Customized ≥12 years - <18 years	10 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	18 Participants n=115 Participants
Age, Customized ≥18 years - <65 years	92 Participants n=93 Participants	50 Participants n=4 Participants	31 Participants n=27 Participants	12 Participants n=483 Participants	7 Participants n=36 Participants	11 Participants n=10 Participants	203 Participants n=115 Participants
Age, Customized ≥65 years	2 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants
Sex: Female, Male Female	46 Participants n=93 Participants	30 Participants n=4 Participants	9 Participants n=27 Participants	3 Participants n=483 Participants	3 Participants n=36 Participants	7 Participants n=10 Participants	98 Participants n=115 Participants
Sex: Female, Male Male	58 Participants n=93 Participants	26 Participants n=4 Participants	24 Participants n=27 Participants	11 Participants n=483 Participants	5 Participants n=36 Participants	4 Participants n=10 Participants	128 Participants n=115 Participants
Race/Ethnicity, Customized Race · Asian	19 Participants n=93 Participants	13 Participants n=4 Participants	5 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants	39 Participants n=115 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race/Ethnicity, Customized Race · White	80 Participants n=93 Participants	41 Participants n=4 Participants	27 Participants n=27 Participants	12 Participants n=483 Participants	7 Participants n=36 Participants	9 Participants n=10 Participants	176 Participants n=115 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Race · Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants n=93 Participants	54 Participants n=4 Participants	32 Participants n=27 Participants	11 Participants n=483 Participants	7 Participants n=36 Participants	11 Participants n=10 Participants	216 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline to Week 48

Population: Full analysis set included all randomized participants who received at least 1 dose of randomized treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=104 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=56 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=33 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=14 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Daily Mean Area Under The Effect-time Curve (AUEC) of Directly Measured Non-ceruloplasmin-bound Copper (dNCC) From 0 to 48 Weeks (dNCC AUEC0-48W)	2.50 micromoles (µmol)*hours (hr)/liter (L) Standard Error 0.150 • Interval 0.15 to	0.87 micromoles (µmol)*hours (hr)/liter (L) Standard Error 0.204 • Interval 0.204 to	4.76 micromoles (µmol)*hours (hr)/liter (L) Standard Error 0.319 • Interval 0.319 to	0.96 micromoles (µmol)*hours (hr)/liter (L) Standard Error 0.487 • Interval 0.487 to

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Safety analysis set included all participants who received at least 1 dose of randomized treatment.

An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. TEAEs were defined as those AEs with onset after the first dose of randomized treatment or existing events that worsened in severity after the first dose of randomized treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=104 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=56 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=33 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=14 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	89 Participants	41 Participants	30 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

The UWDRS comprises 3 parts: UWDRS Part I (level of consciousness, item 1), UWDRS Part II (a patient-reported review of daily activity items \[disability\], items 2 to 11 \[10 items in total\]), and UWDRS Part III (a detailed neurological examination, items 12 to 34 \[23 items in total\]). The UWDRS Part II total score was calculated as the sum of Question 2 to Question 11 (each question has range 0 \[none\] to 4 \[severe\]). The UWDRS Part II total score ranges from 0 (no disability) to 40 (severe disability), with lower score indicating improvement in condition and a better outcome. Change from baseline was calculated as: postbaseline assessment value - baseline assessment value when both values were not missing.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=92 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=50 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=29 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=12 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Change From Baseline in the Unified Wilson Disease Rating Scale (UWDRS) Part II Total Score at Week 48	-0.7 units on a scale Standard Deviation 2.75 • Interval 2.75 to	0.0 units on a scale Standard Deviation 2.31 • Interval 2.31 to	-0.5 units on a scale Standard Deviation 3.23 • Interval 3.23 to	-1.8 units on a scale Standard Deviation 4.63 • Interval 4.63 to

SECONDARY outcome

Timeframe: Baseline, Week 48

The UWDRS comprises 3 parts: UWDRS Part I (level of consciousness, item 1), UWDRS Part II (a patient-reported review of daily activity items \[disability\], items 2 to 11 \[10 items in total\]), and UWDRS Part III (a detailed neurological examination, items 12 to 34 \[23 items in total\]). The UWDRS Part I and III was assessed by a neurologist who was blinded to the treatment randomization. The UWDRS Part III total score was calculated as the sum of Question 12 to Question 34. The UWDRS Part III total score ranges from 0 (normal) to 175 (severe disease), with lower score indicating improvement in condition and a better outcome. Change from baseline was calculated as: postbaseline assessment value - baseline assessment value when both values were not missing.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=91 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=49 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=28 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=11 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Change From Baseline in UWDRS Part III Total Score at Week 48	-2.24 units on a scale Standard Deviation 7.458 • Interval 7.458 to	-1.59 units on a scale Standard Deviation 6.188 • Interval 6.188 to	-2.06 units on a scale Standard Deviation 9.843 • Interval 9.843 to	1.55 units on a scale Standard Deviation 5.889 • Interval 5.889 to

SECONDARY outcome

Timeframe: Baseline, Week 48

UWDRS Part III Functional Subscale consists of speech, handwriting, arising from chair, and gait from UWDRS Part III. The standardized score of the first 3 items ranges from 0 (normal) to 10 (worst), and standardized transformed score of gait ranges from 0 (normal) to 10 (worst). The average of these scores was used to create the Part III Functional Subscale with a range of 0 (normal) - 10 (worst) with higher scores indicating more functional disability.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=91 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=49 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=28 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=11 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Change From Baseline in UWDRS Part III Functional Subscale Score at Week 48	-0.165 units on a scale Standard Deviation 0.7620 • Interval 0.762 to	-0.102 units on a scale Standard Deviation 0.5467 • Interval 0.5467 to	-0.090 units on a scale Standard Deviation 0.8464 • Interval 0.8464 to	0.227 units on a scale Standard Deviation 0.4214 • Interval 0.4214 to

SECONDARY outcome

Timeframe: Baseline, Week 48

UWDRS Part III individual items speech, handwriting, arising from chair, and gait are reported here. For speech (Question 12), original score ranges from 0 (normal) to 4 (unintelligible). For handwriting (Question 20), original score ranges from 0 (normal) to 4 (cannot hold a pen). For arising from chair (Question 27), original score ranges from 0 (normal) to 4 (unable to arise without help). For gait (Question 29), the original score (range: 0 \[normal\] to 10 \[severe condition\]) was calculated by summing subscores (0 \[normal\] to 4 \[severe\]) of Part A (Right and Left Leg dystonia), B (Ataxia), and C (Parkinsonism).

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=91 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=49 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=28 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=11 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48 Speech	-0.1 units on a scale Standard Deviation 0.50	0.0 units on a scale Standard Deviation 0.35	-0.1 units on a scale Standard Deviation 0.52	0.1 units on a scale Standard Deviation 0.54
Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48 Handwriting	-0.2 units on a scale Standard Deviation 0.63	-0.1 units on a scale Standard Deviation 0.48	0.1 units on a scale Standard Deviation 0.60	0.2 units on a scale Standard Deviation 0.40
Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48 Arising from a chair	0.0 units on a scale Standard Deviation 0.45	-0.1 units on a scale Standard Deviation 0.56	0.0 units on a scale Standard Deviation 0.27	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48 Gait	-0.03 units on a scale Standard Deviation 1.317	0.00 units on a scale Standard Deviation 1.141	-0.18 units on a scale Standard Deviation 0.945	0.23 units on a scale Standard Deviation 0.754

SECONDARY outcome

Timeframe: Week 48

The CGI-I is a 7-point scale where the clinician assessed how much participant's illness improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=92 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=50 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=27 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=12 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Clinical Global Impression-Improvement Scale (CGI-I) Score at Week 48	3.4 units on a scale Standard Deviation 0.89 • Interval 0.89 to	3.8 units on a scale Standard Deviation 0.80 • Interval 0.8 to	3.1 units on a scale Standard Deviation 1.06 • Interval 1.06 to	3.2 units on a scale Standard Deviation 1.34 • Interval 1.34 to

SECONDARY outcome

Timeframe: Baseline, Week 48

The CGI-S is a 7-point scale where the investigator rated severity of participant's illness at the time of assessment, relative to the investigator's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant was assessed on severity of illness at time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=89 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=47 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=27 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=11 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Week 48	-0.4 units on a scale Standard Deviation 0.79 • Interval 0.79 to	-0.1 units on a scale Standard Deviation 0.73 • Interval 0.73 to	-0.6 units on a scale Standard Deviation 1.11 • Interval 1.11 to	-0.5 units on a scale Standard Deviation 1.21 • Interval 1.21 to

SECONDARY outcome

Timeframe: Baseline, Week 48

The MELD score uses the participant's values for bilirubin, creatinine, and the international normalized ratio (INR). The initial MELD score (MELD\[i\]) is calculated according to the following formula: MELD(i) = 3.78\*ln\[serum bilirubin (mg/dL)\] + 11.2\*ln\[INR\] + 9.57\*ln\[serum creatinine (mg/dL)\] + 6.43. Creatinine, bilirubin, and INR values less than 1.0 are set to 1.0 and creatinine values greater than 4.0 are set to 4.0 when calculating MELD(i). Additionally, creatinine, bilirubin, and INR are rounded to the 10th decimal place prior to performing the calculation. The initial MELD score is then rounded to the nearest integer. The MELD score ranges from 6 (least sick) - 40 (most sick), with higher values indicating more advanced disease.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=86 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=49 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=28 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=11 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Change From Baseline in Model for End-Stage Liver Disease (MELD) Score at Week 48	-0.1 units on a scale Standard Deviation 1.85 • Interval 1.85 to	0.1 units on a scale Standard Deviation 1.32 • Interval 1.32 to	-0.7 units on a scale Standard Deviation 1.61 • Interval 1.61 to	0.2 units on a scale Standard Deviation 1.25 • Interval 1.25 to

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Full analysis set: all randomized participants who received at least 1 dose of study drug. 'Overall number of participants analyzed'= participants evaluable for this outcome measure.

cNCC = Plasma Total Copper (Cu) \[micrograms (µg)/L\]-(3.15\*ceruloplasmin \[milligrams (mg)/L\])/63.5 \[µg/µmol\] For ALXN1840-treated participants, cNCC in plasma corrected for amount of Cu bound to ALXN1840 tripartite complex (TPC) cNCCcorrected = (√cNCC- 0.993)2√Mo, (Mo= molybdenum). In calculation of cNCC and cNCCcorrected following rules apply: - For plasma total Cu concentration \<lower limit of quantification (LLOQ), cNCC was considered missing (LLOQ = 20 nanograms \[ng\]/mL); - Serum ceruloplasmin concentration values \<LLOQ are set to 0 (LLOQ = 22.5 mg/L); - Plasma total Mo concentration values \<LLOQ are set to 0 (LLOQ = 1 ng/L); - If cNCC calculation produces a negative result, cNCC was considered missing and cNCCcorrected was not derived; - cNCCcorrected was set to 0 when 0.993√Mo \> √cNCC.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=63 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=29 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=26 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=10 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Absolute Change From Baseline in Calculated Non-Ceruloplasmin Bound Copper (cNCC) or Calculated Non-Ceruloplasmin Bound Copper Corrected (cNCCcorrected) in Plasma at Week 48	-0.72 µmol/L Standard Deviation 1.107 • Interval 1.107 to	0.64 µmol/L Standard Deviation 2.769 • Interval 2.769 to	-1.95 µmol/L Standard Deviation 1.536 • Interval 1.536 to	-1.51 µmol/L Standard Deviation 2.361 • Interval 2.361 to

SECONDARY outcome

Timeframe: Baseline, Week 48

cNCC \[µmol/L\] = Plasma Total Cu \[µg/L\]-(3.15\*ceruloplasmin \[mg/L\])/63.5 \[µg/µmol\] For ALXN1840-treated participants, cNCC in plasma was corrected for amount of Cu bound to the ALXN1840 TPC using square root-based cNCC correction method: cNCCcorrected = (√cNCC- 0.993)2√Mo, where Mo = molybdenum. In calculation of cNCC and cNCCcorrected following rules apply: - For plasma total Cu concentration values \<LLOQ, cNCC was considered missing (LLOQ = 20 ng/mL); - Serum ceruloplasmin concentration values \<LLOQ are set to 0 (LLOQ = 22.5 mg/L); - Plasma total Mo concentration values \<LLOQ are set to 0 (LLOQ = 1 ng/L); - In cases where cNCC calculation produces a negative result, cNCC was considered missing and cNCCcorrected was not derived; - cNCCcorrected was set to 0 when 0.993√Mo \> √cNCC.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=60 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=28 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=26 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=10 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
Percent Change From Baseline in cNCC or cNCCcorrected in Plasma at Week 48	-7.7 percent change Standard Deviation 263.20 • Interval 263.2 to	104.6 percent change Standard Deviation 292.11 • Interval 292.11 to	-64.0 percent change Standard Deviation 42.88 • Interval 42.88 to	-44.3 percent change Standard Deviation 68.82 • Interval 68.82 to

SECONDARY outcome

Timeframe: Week 48

Population: Full analysis set included all randomized participants who received at least 1 dose of randomized treatment.

cNCC/cNCCcorrected responder was defined as participants who achieved or maintained normalized cNCC/cNCCcorrected concentration (0.8-2.3 μmol) within (at or before) 48 weeks or reached a reduction of at least 25% in cNCC/cNCCcorrected within 48 weeks. Thus, a participant was considered a cNCC/cNCCcorrected responder if they met at least 1 of the following criteria: - Achieved normalized cNCC/cNCCcorrected concentration for 2 consecutive measurements within 48 weeks, for participants who had elevated cNCC concentrations at baseline; - Maintained normalized cNCC/cNCCcorrected concentration within 48 weeks, for participants who had normal cNCC concentrations at baseline; - Reached a reduction of at least 25% in cNCC/cNCCcorrected for 2 consecutive measurements within 48 weeks.

Outcome measures

Outcome measures
Measure	Cohort 1: ALXN1840 n=104 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 1: SoC Therapy n=56 Participants Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 2: ALXN1840 n=33 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	Cohort 2: SoC Therapy n=14 Participants Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy according to the local package label for up to 48 weeks in PEP. Participants who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.
cNCC/cNCCcorrected Responder at Week 48	101 Participants	39 Participants	33 Participants	13 Participants

Adverse Events

PEP Cohort 1: ALXN1840

Serious events: 14 serious events

Other events: 46 other events

Deaths: 1 deaths

PEP Cohort 1: SoC Therapy

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

PEP Cohort 2: ALXN1840

Serious events: 4 serious events

Other events: 16 other events

Deaths: 1 deaths

PEP Cohort 2: SoC Therapy

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

OLE Cohort 1: ALXN1840

Serious events: 20 serious events

Other events: 45 other events

Deaths: 1 deaths

OLE Cohort 1: SoC Therapy

Serious events: 10 serious events

Other events: 32 other events

Deaths: 0 deaths

OLE Cohort 2: ALXN1840

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

OLE Cohort 2: SoC Therapy

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 1: WTX101-201- ALXN1840

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2: WTX101-201- ALXN1840

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PEP Cohort 1: ALXN1840 n=104 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks.	PEP Cohort 1: SoC Therapy n=56 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy for up to 48 weeks according to the local package label.	PEP Cohort 2: ALXN1840 n=33 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks.	PEP Cohort 2: SoC Therapy n=14 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy for up to 48 weeks according to the local package label.	OLE Cohort 1: ALXN1840 n=89 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) who completed the 48-week PEP of study WTX101-301 were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	OLE Cohort 1: SoC Therapy n=49 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) who completed the 48-week PEP of study WTX101-301 were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	OLE Cohort 2: ALXN1840 n=28 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	OLE Cohort 2: SoC Therapy n=12 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 1: WTX101-201- ALXN1840 n=8 participants at risk Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months.	Cohort 2: WTX101-201- ALXN1840 n=11 participants at risk Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months.
General disorders Unevaluable event	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Delusion	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Blood and lymphatic system disorders Leukopenia	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Congenital, familial and genetic disorders Hepato-lenticular degeneration	1.9% 2/104 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Varices oesophageal	0.96% 1/104 • Number of events 3 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Hepatobiliary disorders Hypertransaminasaemia	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Hepatobiliary disorders Liver disorder	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Epididymitis	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Urinary tract infection	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Urosepsis	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Cystitis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Pneumonia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Facial bones fracture	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Intentional overdose	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Cellulitis	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Investigations Blood creatine phosphokinase increased	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.96% 1/104 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Syncope	1.9% 2/104 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Balance disorder	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Dystonia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Hepatic encephalopathy	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Neurological decompensation	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Epilepsy	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Product Issues Device malfunction	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Paranoia	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Persistent depressive disorder	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Suicidal ideation	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.96% 1/104 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Vascular disorders Venous thrombosis limb	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Cardiac disorders Coronary artery occlusion	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.5% 1/8 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Cardiac disorders Myocardial infarction	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Cardiac disorders Supraventricular tachyarrhythmia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Cardiac disorders Tachycardia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Constipation	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Gastritis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Vomiting	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	4.1% 2/49 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Herpes simplex hepatitis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Pyelonephritis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Retroperitoneal abscess	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Investigations Alanine aminotransferase increased	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Investigations Hepatic enzyme increased	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Metabolism and nutrition disorders Malnutrition	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.5% 1/8 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Fracture malunion	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma recurrent	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Dyskinesia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Product Issues Device dislocation	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Alcoholism	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Depression	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Mental disorder	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	2.0% 1/49 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Reproductive system and breast disorders Uterine cyst	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.1% 1/89 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Gastrointestinal disorders Umbilical hernia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Sports injury	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Neurological symptom	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Sciatica	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Mania	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Panic attack	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Psychiatric disorders Suicide attempt	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Renal and urinary disorders Urethral stenosis	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.

Other adverse events

Other adverse events
Measure	PEP Cohort 1: ALXN1840 n=104 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) received titrated doses of ALXN1840 orally for up to 48 weeks.	PEP Cohort 1: SoC Therapy n=56 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) continued to receive SoC therapy for up to 48 weeks according to the local package label.	PEP Cohort 2: ALXN1840 n=33 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received titrated doses of ALXN1840 orally for up to 48 weeks.	PEP Cohort 2: SoC Therapy n=14 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) received SoC therapy for up to 48 weeks according to the local package label.	OLE Cohort 1: ALXN1840 n=89 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) who completed the 48-week PEP of study WTX101-301 were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	OLE Cohort 1: SoC Therapy n=49 participants at risk Participants in Cohort 1 (who received SoC therapy, that is, chelation therapy with penicillamine or trientine, zinc therapy, or a combination of both chelation and zinc therapy for \>28 days) who completed the 48-week PEP of study WTX101-301 were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	OLE Cohort 2: ALXN1840 n=28 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and continued to receive ALXN1840 for up to 60 months.	OLE Cohort 2: SoC Therapy n=12 participants at risk Participants in Cohort 2 (who were treatment naïve or who received SoC therapy for ≤28 days) who completed the 48-week PEP were offered the opportunity to participate in the OLE Period and received ALXN1840 for up to 60 months.	Cohort 1: WTX101-201- ALXN1840 n=8 participants at risk Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months.	Cohort 2: WTX101-201- ALXN1840 n=11 participants at risk Participants who received ALXN1840 during Study WTX101-201 (NCT02273596) continued to receive ALXN1840 for up to 60 months.
Gastrointestinal disorders Nausea	5.8% 6/104 • Number of events 6 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	6.1% 2/33 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	14.3% 2/14 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	6.7% 6/89 • Number of events 10 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	6.1% 3/49 • Number of events 5 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.5% 1/8 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Nasopharyngitis	10.6% 11/104 • Number of events 14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	17.9% 10/56 • Number of events 12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.1% 4/33 • Number of events 4 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	14.3% 2/14 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	10.1% 9/89 • Number of events 14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.2% 6/49 • Number of events 6 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	7.1% 2/28 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	25.0% 3/12 • Number of events 3 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Upper respiratory tract infection	7.7% 8/104 • Number of events 9 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	5.4% 3/56 • Number of events 3 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Investigations Alanine aminotransferase increased	18.3% 19/104 • Number of events 24 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.0% 1/33 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	7.1% 1/14 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.0% 8/89 • Number of events 13 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	26.5% 13/49 • Number of events 16 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	7.1% 2/28 • Number of events 5 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.5% 1/8 • Number of events 8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Headache	6.7% 7/104 • Number of events 7 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	5.4% 3/56 • Number of events 8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.1% 4/33 • Number of events 5 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	21.4% 3/14 • Number of events 3 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.0% 8/89 • Number of events 10 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.2% 6/49 • Number of events 13 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	8.3% 1/12 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.5% 1/8 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Nervous system disorders Tremor	5.8% 6/104 • Number of events 8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	1.8% 1/56 • Number of events 3 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.1% 4/33 • Number of events 4 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	7.1% 1/14 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/89 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/49 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
General disorders Fatigue	8.7% 9/104 • Number of events 12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 2/56 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.1% 4/33 • Number of events 4 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	7.1% 1/14 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	4.5% 4/89 • Number of events 5 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.2% 6/49 • Number of events 6 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	3.6% 1/28 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/8 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	9.1% 1/11 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations COVID-19	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	24.7% 22/89 • Number of events 23 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	24.5% 12/49 • Number of events 12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	21.4% 6/28 • Number of events 7 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	33.3% 4/12 • Number of events 5 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	25.0% 2/8 • Number of events 2 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	63.6% 7/11 • Number of events 7 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.
Infections and infestations Urinary tract infection	0.00% 0/104 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/56 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/33 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/14 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	5.6% 5/89 • Number of events 13 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	10.2% 5/49 • Number of events 5 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/28 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/12 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	12.5% 1/8 • Number of events 1 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.	0.00% 0/11 • For PEP participants: From Primary Evaluation Period Baseline up to Primary Evaluation Period Week 48/Early Termination; For OLE and WTX101-201 participants: From Extension Period Week 1 up to Extension Period Week 268/Early Termination Safety analysis set included all participants who received at least 1 dose of randomized treatment.

Additional Information

Alexion Pharmaceuticals Inc.

Phone: +1 855-752-2356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place