Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain. (NCT NCT05025787)

Last Updated: 2025-11-26

Results Overview

The primary outcome measure used to assess efficacy will be patient-reported knee pain using the WOMAC Part A (Bellamy, et al., 1988).We will use the numerical rating scale version of the WOMAC, with the subject assessing each of 5 questions using an 11-point (0 to 10) scale; the total score is the sum of the individual item scores (range 0-50). A higher WOMAC score represents worse symptom severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

24 Weeks

Results posted on

2025-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	300mg BID, Then Placebo Participants initially received 300 mg BID of CNTX-6970 for 6 weeks (Block 1, Period 1). Following this, they were administered matching placebo BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received 300 mg BID of CNTX-6970 again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received matching placebo for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.	Placebo, Then 300 mg CNTX-6970 BID Participants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered CNTX-6970 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
Overall Study STARTED	28	27
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	300mg BID, Then Placebo Participants initially received 300 mg BID of CNTX-6970 for 6 weeks (Block 1, Period 1). Following this, they were administered matching placebo BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received 300 mg BID of CNTX-6970 again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received matching placebo for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.	Placebo, Then 300 mg CNTX-6970 BID Participants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered CNTX-6970 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
Overall Study Lack of Efficacy	0	1
Overall Study Adverse Event	2	4
Overall Study Non compliance	0	1
Overall Study Protocol Violation	3	1
Overall Study Stopping criteria met	1	1
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300mg BID, Then Placebo (DPPD) n=28 Participants Participants initially received 300 mg BID of CNTX-6970 for 6 weeks (Block 1, Period 1). Following this, they were administered matching placebo BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received 300 mg BID of CNTX-6970 again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received matching placebo for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.	Placebo, Then 300 mg CNTX-6970 BID (PDDP) n=27 Participants Participants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered CNTX-6970 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=492 Participants	14 Participants n=492 Participants	33 Participants n=984 Participants
Age, Categorical >=65 years	9 Participants n=492 Participants	13 Participants n=492 Participants	22 Participants n=984 Participants
Sex: Female, Male Female	21 Participants n=492 Participants	22 Participants n=492 Participants	43 Participants n=984 Participants
Sex: Female, Male Male	7 Participants n=492 Participants	5 Participants n=492 Participants	12 Participants n=984 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=492 Participants	5 Participants n=492 Participants	14 Participants n=984 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=492 Participants	21 Participants n=492 Participants	40 Participants n=984 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=492 Participants	1 Participants n=492 Participants	1 Participants n=984 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) Asian	0 Participants n=492 Participants	1 Participants n=492 Participants	1 Participants n=984 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) Black or African American	8 Participants n=492 Participants	5 Participants n=492 Participants	13 Participants n=984 Participants
Race (NIH/OMB) White	20 Participants n=492 Participants	19 Participants n=492 Participants	39 Participants n=984 Participants
Race (NIH/OMB) More than one race	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=492 Participants	2 Participants n=492 Participants	2 Participants n=984 Participants
Region of Enrollment United States	28 participants n=492 Participants	27 participants n=492 Participants	55 participants n=984 Participants
Moderate to severe knee pain stable for 6 months	28 Participants n=492 Participants	27 Participants n=492 Participants	55 Participants n=984 Participants
Confirmation of Knee OA by central radiologist	28 Participants n=492 Participants	27 Participants n=492 Participants	55 Participants n=984 Participants
Two or more failed therapies	28 Participants n=492 Participants	27 Participants n=492 Participants	55 Participants n=984 Participants
mid-high lain score as defined by the WOMAC-A and NRSs	28 Participants n=492 Participants	27 Participants n=492 Participants	55 Participants n=984 Participants
BMI less than or equal to 40	28 Participants n=492 Participants	27 Participants n=492 Participants	55 Participants n=984 Participants
Compliant with study requirements before the baseline visit	28 Participants n=492 Participants	27 Participants n=492 Participants	55 Participants n=984 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Intension-to-Treat (ITT) - All randomized participants

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=17 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=16 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=26 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=21 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=23 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=19 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)	19.4 Score on a scale Standard Deviation 9.6	16.8 Score on a scale Standard Deviation 9.6	22.5 Score on a scale Standard Deviation 12.5	18.6 Score on a scale Standard Deviation 12.5	18.9 Score on a scale Standard Deviation 10.1	18.2 Score on a scale Standard Deviation 11.6	18.3 Score on a scale Standard Deviation 13.1	18.6 Score on a scale Standard Deviation 11.9

PRIMARY outcome

Timeframe: 24 Weeks

Population: Intension-to-Treat (ITT) - All randomized participants

The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), reported between the administration of study drug on Day 1 and the completion of the study at week 24 or early termination.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=19 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=17 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=28 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=25 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=27 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=23 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=20 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Treatment Emergent Adverse Events (TEAEs)	7 Participants	3 Participants	14 Participants	7 Participants	14 Participants	7 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Intension-to-Treat (ITT) - All randomized participants

Daily Knee Pain Intensity on a 0-10 Numeric Rating Scale (NRS). Pain intensity is reported by patients with chronic pain as one of the most important targets of treatment, and daily pain intensity ratings are a recommended core outcome measure for clinical trials of treatments for chronic pain. Daily ratings are preferable to ratings of recalled pain over longer time periods such as a week, as daily ratings minimize the influence of recall biases (Dworkin et al., 2005). Participants provide one-daily reports (at the end of the day) of their average knee pain intensity on a 0-10 pain intensity NRS over the course of a week, and those daily ratings are averaged to compute a mean knee pain intensity score. Participants will record their Daily Pain Intensity Numeric Rating Scale (NRS) 0-10 each day for one week prior to each clinic visit using NEForm. Lower NRS values correspond to less pain.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=11 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=10 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=21 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=13 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=11 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=15 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=15 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=11 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Numeric Rating Scale (NRS)	4.5 units on a scale Standard Deviation 2.3	3.5 units on a scale Standard Deviation 2.7	4.8 units on a scale Standard Deviation 2.4	3.8 units on a scale Standard Deviation 2.4	4.4 units on a scale Standard Deviation 2.3	4.3 units on a scale Standard Deviation 2.4	3.8 units on a scale Standard Deviation 2.9	4.7 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 24 Weeks

Population: Intension-to-Treat (ITT) - All randomized participants

WOMAC-C (Function subscale) (Bellamy et al, 1988). The WOMAC-physical function subscale contains 17 items assessing daily functioning, each using an 11-point (0 to 10) numerical rating scale. The total index score (0-170) is the sum of the items. A higher WOMAC function score represents worse functioning and less ability to engage in daily activities.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=17 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=16 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=26 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=21 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=23 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=19 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C)	61.4 units on a scale Standard Deviation 32.9	54.9 units on a scale Standard Deviation 36.2	72.0 units on a scale Standard Deviation 39.9	59.8 units on a scale Standard Deviation 41.4	58.7 units on a scale Standard Deviation 37.4	55.2 units on a scale Standard Deviation 40.2	60.4 units on a scale Standard Deviation 44.0	63.7 units on a scale Standard Deviation 39.1

SECONDARY outcome

Timeframe: 24 Weeks

Population: Participants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered CNTX-6970 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.

The HADS is a 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in those with medical illness (Norton et al, 2013). This scale has 14 items, 7 related to anxiety and 7 to depression, rated on 4 points (0 to 3) in domains of intensity or frequency. Scoring is done separately for depression and for anxiety and each domain is interpreted as normal for scores of 0-7, borderline abnormal (borderline case) for scores of 8-10 and abnormal (case) for scores of 11-21. This scale is used to assess depression and anxiety in addition to HEAL/EPPIC-Net core data elements (CDEs) because of its higher sensitivity to change especially in patients with medical illnesses.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=17 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=16 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=26 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=21 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=23 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=19 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Hospital Anxiety and Depression Scale (HADS) - Anxiety	1.9 units on a scale Standard Deviation 2.4	2.1 units on a scale Standard Deviation 2.4	2.9 units on a scale Standard Deviation 2.5	2.2 units on a scale Standard Deviation 2.4	2.8 units on a scale Standard Deviation 2.3	1.9 units on a scale Standard Deviation 2.5	2.7 units on a scale Standard Deviation 2.6	2.2 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 24 Weeks

Population: Intension-to-Treat (ITT) - All randomized participants

The PGIC is a single-item measure of patient-reported improvement that is widely used as a general outcome measure in studies of chronic pain patients, including OA patients (Salaff et al, 2004). It is often used as an index of treatment-associated change, and patient-reported improvements in the form of PGIC scores correlate robustly with significant improvement in pain intensity, pain interference with activities of daily living, mood, and quality of life (Perrot and Lanteri-Minet, 2019). The PCIC was collected at baseline and week 24. PGIC is scored from 0-6, where lower values correspond to better outcomes (e.g., 0 = very much improved, whereas 6 is very much worse).

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=16 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Patient Global Impression of Change (PGIC)	—	—	1.6 units on a scale Standard Deviation 1.2	1.8 units on a scale Standard Deviation 1.2	—	—	—	—

SECONDARY outcome

Timeframe: 24 Weeks

Population: Per Protocol: All randomized participants excluding participants with major protocol deviations. Major protocol deviations are those with early terminated from the study and those who had inclusion/exclusion criteria deviation or a treatment dispensing error judged to be significant by study leadership. In this study, only one participant had a treatment dispending error.

Assessed at baseline and at the end of each treatment period (weeks 6, 12, 18, and 24).Serum levels are measured in Picograms per millilitre (pg/mL). Analyses were performed for Aim 5 to assess the efficacy of CNTX-6970 (300mg BID) in comparison to placebo in biomarkers from (b) serum and synovial fluid levels of chemokines and cytokines; and (c) Synovial monocyte chemoattractant protein-1/CCR-2 receptor binding inhibition in blood and synovial fluid. The following 9 biomarkers had sufficient data based on either the ability to fit models A and/or B and at least 50% of the values were above the minimum detectable threshold: Alpha.2.Macroglobulin..A2Macro, Immunoglobulin.A..IgA, Macrophage.Inflammatory.Protein.1.beta..MIP.1.beta, Monocyte.Chemotactic.Protein.1..MCP.1, Serum.Amyloid.P.Component..SAP,

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=10 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=11 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=15 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=16 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=7 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=10 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=15 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=16 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Serum Levels of Cytokines and Chemokines Serum Amyloid P Component	2.7 log(pg/mL) Standard Deviation 0.2	2.8 log(pg/mL) Standard Deviation 0.3	2.6 log(pg/mL) Standard Deviation 0.3	2.6 log(pg/mL) Standard Deviation 0.2	2.6 log(pg/mL) Standard Deviation 0.3	2.6 log(pg/mL) Standard Deviation 0.3	2.7 log(pg/mL) Standard Deviation 0.2	2.6 log(pg/mL) Standard Deviation 0.3
Serum Levels of Cytokines and Chemokines Thyroxine Binding Globulin	3.9 log(pg/mL) Standard Deviation 0.2	3.9 log(pg/mL) Standard Deviation 0.2	3.8 log(pg/mL) Standard Deviation 0.3	3.9 log(pg/mL) Standard Deviation 0.2	3.8 log(pg/mL) Standard Deviation 0.2	3.9 log(pg/mL) Standard Deviation 0.1	3.9 log(pg/mL) Standard Deviation 0.3	3.8 log(pg/mL) Standard Deviation 0.3
Serum Levels of Cytokines and Chemokines Vitamin D Binding Protein	5.7 log(pg/mL) Standard Deviation 0.3	5.7 log(pg/mL) Standard Deviation 0.4	5.5 log(pg/mL) Standard Deviation 0.4	5.6 log(pg/mL) Standard Deviation 0.3	5.5 log(pg/mL) Standard Deviation 0.4	5.6 log(pg/mL) Standard Deviation 0.2	5.6 log(pg/mL) Standard Deviation 0.4	5.6 log(pg/mL) Standard Deviation 0.4
Serum Levels of Cytokines and Chemokines Von Willebrand Factor	5.3 log(pg/mL) Standard Deviation 0.4	5.3 log(pg/mL) Standard Deviation 0.4	5.1 log(pg/mL) Standard Deviation 0.5	5.1 log(pg/mL) Standard Deviation 0.5	5.6 log(pg/mL) Standard Deviation 0.2	5.1 log(pg/mL) Standard Deviation 0.7	5.2 log(pg/mL) Standard Deviation 0.6	5.1 log(pg/mL) Standard Deviation 0.6
Serum Levels of Cytokines and Chemokines T Cell Specific Protein RANTES	3.0 log(pg/mL) Standard Deviation 0.5	3.0 log(pg/mL) Standard Deviation 0.7	2.9 log(pg/mL) Standard Deviation 0.7	3.0 log(pg/mL) Standard Deviation 0.5	3.0 log(pg/mL) Standard Deviation 0.5	3.0 log(pg/mL) Standard Deviation 0.9	2.7 log(pg/mL) Standard Deviation 0.9	2.9 log(pg/mL) Standard Deviation 0.7
Serum Levels of Cytokines and Chemokines Monocyte Chemotactic Protein 1	7.5 log(pg/mL) Standard Deviation 0.7	5.9 log(pg/mL) Standard Deviation 0.6	7.4 log(pg/mL) Standard Deviation 0.6	6.1 log(pg/mL) Standard Deviation 0.6	6.0 log(pg/mL) Standard Deviation 0.5	7.3 log(pg/mL) Standard Deviation 0.7	6.0 log(pg/mL) Standard Deviation 0.5	7.0 log(pg/mL) Standard Deviation 1.0
Serum Levels of Cytokines and Chemokines Macrophage Inflammatory Protein 1 beta	6.9 log(pg/mL) Standard Deviation 0.3	6.0 log(pg/mL) Standard Deviation 0.8	7.0 log(pg/mL) Standard Deviation 0.8	6.7 log(pg/mL) Standard Deviation 0.8	6.4 log(pg/mL) Standard Deviation 0.6	6.8 log(pg/mL) Standard Deviation 0.6	6.5 log(pg/mL) Standard Deviation 0.7	6.9 log(pg/mL) Standard Deviation 0.7
Serum Levels of Cytokines and Chemokines Alpha 2 Macroglobulin	1.2 log(pg/mL) Standard Deviation 0.2	1.2 log(pg/mL) Standard Deviation 0.2	1.0 log(pg/mL) Standard Deviation 0.3	1.1 log(pg/mL) Standard Deviation 0.3	1.2 log(pg/mL) Standard Deviation 0.2	1.2 log(pg/mL) Standard Deviation 0.2	1.0 log(pg/mL) Standard Deviation 0.3	1.0 log(pg/mL) Standard Deviation 0.3
Serum Levels of Cytokines and Chemokines Immunoglobulin A IgA	0.9 log(pg/mL) Standard Deviation 0.6	0.8 log(pg/mL) Standard Deviation 0.6	0.4 log(pg/mL) Standard Deviation 1.3	0.6 log(pg/mL) Standard Deviation 1.3	1.1 log(pg/mL) Standard Deviation 0.4	1.0 log(pg/mL) Standard Deviation 0.6	0.6 log(pg/mL) Standard Deviation 1.4	0.6 log(pg/mL) Standard Deviation 1.5

SECONDARY outcome

Timeframe: 24 Weeks

Population: ITT - Intention to Treat

Monocyte chemoattractant serum protein-1(MCP-1)/CCR-2 receptor binding inhibition by CNTX-6970. This will be assessed at baseline and at the end of each treatment period (weeks 6, 12, 18 and 24). The data is measured in pg per mL, the data in analyzed in the natural log of pg per mL, with higher numbers indicating more binding inhibition.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=18 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=22 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=22 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=18 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=19 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=17 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
MCP-1/CCR-2	387.7 natural log(pg/mL) Standard Deviation 330.7	0 natural log(pg/mL) Standard Deviation 0	133.8 natural log(pg/mL) Standard Deviation 246.9	0 natural log(pg/mL) Standard Deviation 0	0 natural log(pg/mL) Standard Deviation 0	312.8 natural log(pg/mL) Standard Deviation 327.7	87.4 natural log(pg/mL) Standard Deviation 380.8	140.5 natural log(pg/mL) Standard Deviation 234.1

SECONDARY outcome

Timeframe: 24 Weeks

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=17 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=16 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=26 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=21 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=23 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=19 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Hospital Anxiety and Depression Scale (HADS) - Depression	1.3 units on a scale Standard Deviation 1.4	1.4 units on a scale Standard Deviation 1.5	2.2 units on a scale Standard Deviation 2.1	2.0 units on a scale Standard Deviation 2.5	1.6 units on a scale Standard Deviation 1.5	1.1 units on a scale Standard Deviation 1.2	1.6 units on a scale Standard Deviation 2.0	2.2 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 24 Weeks

PROMIS Sleep Disturbance Scale 6A (Yu et al, 2011). Sleep disruption has a bi-directional relationship with chronic pain and is an important secondary outcome to measure in pain trials (Edwards et al, 2016). The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form is a convenient 6-item scale that correlates strongly with the longer forms. It shows greater measurement precision for assessing sleep disturbance than other commonly-used (and much longer) questionnaires such as the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale; its brevity and convenience are a major advantage for both research and clinical settings (Yu et al, 2011). 60 is the most commonly used threshold for clinically significant sleep. The PROMIS Sleep Disturbance Scale is expressed as a T-score, with a population mean of 50 and SD of 10. A higher T-score indicates better physical functioning. Possible T scores in this distribution range from 31.7 to 76.1.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=17 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=16 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=15 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=21 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=13 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=19 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=19 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
PROMIS - 6A	48.2 T score Standard Deviation 9.0	46.4 T score Standard Deviation 8.8	48.1 T score Standard Deviation 12.0	48.8 T score Standard Deviation 10.7	45.1 T score Standard Deviation 8.6	48.0 T score Standard Deviation 8.4	46.9 T score Standard Deviation 8.4	48.5 T score Standard Deviation 8.8

SECONDARY outcome

Timeframe: 24 Weeks

Population: ITT - Intention to Treat Population

This procedure consists of stepping fully up and down onto an 8in (20.32cm) high platform with both feet a total of 24 times. The lead leg is alternated between each up/down cycle. Subjects are instructed to use their normal gait for completing this task and are encouraged to complete the task despite increasing pain, without stopping if possible. The procedure is timed, and current knee pain intensity on a 0-10 Numeric Rating Scale (NRS) is assessed immediately before and following the procedure while the subject is in a seated, resting position. Lower values correspond to less pain. The NRS from the post-step was analyzed.

Outcome measures

Outcome measures
Measure	300 mg CNTX-6970 BID (PDDP): B2P1 n=16 Participants Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=15 Participants Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24	300mg BID CNTX-6970 (DPPD): B1P1 n=25 Participants Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (DPPD): B1P2 n=20 Participants Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (PDDP): B1P1 n=22 Participants Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=18 Participants Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=19 Participants Block 2 Period 1: Participants were instructed to take matching placebo BID for weeks 12 through 18	300 mg CNTX-6970 (DPPD): B2P2 n=18 Participants Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24
Staircase-evoked Pain Assessment	4.8 units on a scale Standard Deviation 2.8	4.9 units on a scale Standard Deviation 2.6	4.9 units on a scale Standard Deviation 2.8	3.8 units on a scale Standard Deviation 2.7	3.9 units on a scale Standard Deviation 3.0	4.4 units on a scale Standard Deviation 2.7	3.9 units on a scale Standard Deviation 3.0	3.9 units on a scale Standard Deviation 2.6

Adverse Events

300mg BID CNTX-6970 (DPPD): B1P1

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo BID (PDDP): B1P1

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

300 mg BID CNTX-6970 (PDDP): B1P2

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo BID (DPPD): B1P2

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo BID (DPPD): B2P1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

300 mg CNTX-6970 (DPPD): B2P2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

300 mg CNTX-6970 BID (PDDP): B2P1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo BID (PDDP): B2P2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	300mg BID CNTX-6970 (DPPD): B1P1 n=28 participants at risk Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (PDDP): B1P1 n=27 participants at risk Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=25 participants at risk Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B1P2 n=23 participants at risk Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 participants at risk Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg CNTX-6970 (DPPD): B2P2 n=20 participants at risk Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24	300 mg CNTX-6970 BID (PDDP): B2P1 n=19 participants at risk Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=17 participants at risk Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Blood and lymphatic system disorders chronic myeloid leukaemia	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)

Other adverse events

Other adverse events
Measure	300mg BID CNTX-6970 (DPPD): B1P1 n=28 participants at risk Block 1 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 1 through 6	Placebo BID (PDDP): B1P1 n=27 participants at risk Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg BID CNTX-6970 (PDDP): B1P2 n=25 participants at risk Block 1 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 6 through 12	Placebo BID (DPPD): B1P2 n=23 participants at risk Block 1 Period 2: Participants were instructed to take matching placebo BID for weeks 6 through 12	Placebo BID (DPPD): B2P1 n=20 participants at risk Block 1 Period 1: Participants were instructed to take matching placebo BID for weeks 1 through 6	300 mg CNTX-6970 (DPPD): B2P2 n=20 participants at risk Block 2 Period 2: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 18 through 24	300 mg CNTX-6970 BID (PDDP): B2P1 n=19 participants at risk Block 2 Period 1: Participants were instructed to take 300 mg CNTX-6970 BID for weeks 12 through 18	Placebo BID (PDDP): B2P2 n=17 participants at risk Block 2 Period 2: Participants were instructed to take matching Placebo BID for weeks 18 through 24
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Pain in Extremity	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Joint Stiffness	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Muscle Spasms	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Osteoarthritis	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Bronchitis	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Food poisoning	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Nausea	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Diarrhoea	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Gastrooesophageal reflux disease	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Abdominal distension	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Change of bowel habit	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Dyspepsia	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Flatulence	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Gastritis	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Procedural nausea	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Nasopharyngitis	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Conjunctivitis	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Clostridium difficile infection	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Ear infection	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Influenza	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Upper respiratory tract infection	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Viral infection	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Nervous system disorders Headache	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	11.1% 3/27 • Number of events 3 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Nervous system disorders Dizziness	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Nervous system disorders Somnolence	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Laboratory test abnormal	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Blood creatinine increased	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Blood phosphorus abnormal	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Blood potassium increased	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Blood urea increased	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Lipase abnormal	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Lipase increased	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Platelet count decreased	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Investigations Urine leukocyte esterase	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
General disorders Fatigue	7.1% 2/28 • Number of events 2 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
General disorders Oedema peripheral	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Metabolism and nutrition disorders Increased appetite	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Respiratory, thoracic and mediastinal disorders Cough	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Skin and subcutaneous tissue disorders Rash	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Skin and subcutaneous tissue disorders Onychomadesis	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Skin and subcutaneous tissue disorders Rash papular	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Surgical and medical procedures Cataract operation	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Surgical and medical procedures Eye laser surgery	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Surgical and medical procedures Toe operation	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Surgical and medical procedures Weight loss diet	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Psychiatric disorders Anxiety	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Psychiatric disorders Insomnia	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Vascular disorders Hypertension	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Vascular disorders Hypotension	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Renal and urinary disorders Acute kidney injury	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Renal and urinary disorders Haematuria	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Renal and urinary disorders Nephrolithiasis	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Cardiac disorders Supraventricular tachycardia	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	3.7% 1/27 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Ear and labyrinth disorders Vertigo positional	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Eye disorders Photophobia	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Injury, poisoning and procedural complications Fall	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Injury, poisoning and procedural complications Wrist fracture	3.6% 1/28 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Product Issues Product after taste	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	4.3% 1/23 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
General disorders Chest Discomfort	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
General disorders Gate Disturbance	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
General disorders Ulcer	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
Infections and infestations Urinary Tract Infection	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/17 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)
General disorders Oedema Peripheral	0.00% 0/28 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/27 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/25 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/23 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/20 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	0.00% 0/19 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of consent through study completion or early withdrawal (24 weeks). If ongoing at the end of the study, the subject was referred for appropriate treatment. The investigator or designee was required to record all observed and reported AEs at each visit. All AEs, serious and not serious, were recorded on the AE eCRF page using appropriate medical terminology. Severity and relationship to study drug were assessed by the investigator as described in the protocol. (add in safety populaton)

Additional Information

Allison Campbell

MGH

Phone: 617-595-8372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place