Trial Outcomes & Findings for Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents (NCT NCT00485264)

Last Updated: 2021-11-02

Results Overview

Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

153 participants

Primary outcome timeframe

From study entry through Week 24

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort I Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Overall Study STARTED	71	16	18	21	15	12
Overall Study Completed Week 24	67	16	18	21	14	11
Overall Study COMPLETED	35	9	12	17	9	5
Overall Study NOT COMPLETED	36	7	6	4	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort I Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Overall Study Enrolled But Not Given Treatment	0	0	0	0	1	0
Overall Study Death	1	0	0	0	1	0
Overall Study Adverse Event	1	0	2	3	1	3
Overall Study Pregnancy	4	0	0	0	0	0
Overall Study Disallowed Medication	0	0	0	0	0	1
Overall Study Number/Volume/Timing of Study Meds	2	1	1	0	0	0
Overall Study Lack of Efficacy	0	1	0	0	0	0
Overall Study Guardian Consent Withdrawn	1	0	0	0	1	0
Overall Study Physician Decision	0	2	0	0	0	0
Overall Study Intolerance/Unable to Tolerate Dose	0	0	1	0	0	0
Overall Study Not Able to Attend Clinic	5	0	0	1	1	2
Overall Study Non-Compliant	17	2	1	0	1	0
Overall Study Lost to Follow-up	2	1	1	0	0	1
Overall Study Other Reason	3	0	0	0	0	0

Baseline Characteristics

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I n=71 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=16 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=18 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=21 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data..	Total n=152 Participants Total of all reporting groups
Age, Continuous	15 years STANDARD_DEVIATION 2 • n=5 Participants	9.1 years STANDARD_DEVIATION 1.6 • n=7 Participants	8.9 years STANDARD_DEVIATION 1.6 • n=5 Participants	3.1 years STANDARD_DEVIATION 1.2 • n=4 Participants	1.0 years STANDARD_DEVIATION 0.5 • n=21 Participants	0.3 years STANDARD_DEVIATION 0.1 • n=10 Participants	9.5 years STANDARD_DEVIATION 6.1 • n=115 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=10 Participants	70 Participants n=115 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=10 Participants	82 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=10 Participants	55 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=10 Participants	81 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=10 Participants	16 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	10 Participants n=21 Participants	12 Participants n=10 Participants	97 Participants n=115 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	45 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants
Plasma HIV RNA, continuous	4.3 log10 copies/mL STANDARD_DEVIATION 0.6 • n=5 Participants	4.3 log10 copies/mL STANDARD_DEVIATION 0.6 • n=7 Participants	4.3 log10 copies/mL STANDARD_DEVIATION 0.5 • n=5 Participants	4.4 log10 copies/mL STANDARD_DEVIATION 0.8 • n=4 Participants	5.4 log10 copies/mL STANDARD_DEVIATION 1 • n=21 Participants	6 log10 copies/mL STANDARD_DEVIATION 1.2 • n=10 Participants	4.6 log10 copies/mL STANDARD_DEVIATION 0.9 • n=115 Participants
Plasma HIV RNA, categorical 0 to ≤4,000 copies/mL	10 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	16 participants n=115 Participants
Plasma HIV RNA, categorical >4,000 to ≤50,000 copies/mL	40 participants n=5 Participants	12 participants n=7 Participants	11 participants n=5 Participants	11 participants n=4 Participants	1 participants n=21 Participants	2 participants n=10 Participants	74 participants n=115 Participants
Plasma HIV RNA, categorical >50,000 to ≤100,000 copies/mL	14 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	3 participants n=21 Participants	1 participants n=10 Participants	23 participants n=115 Participants
Plasma HIV RNA, categorical >100,000 copies/mL	7 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	9 participants n=21 Participants	9 participants n=10 Participants	13 participants n=115 Participants
CD4 cell count	410.7 cells/µL STANDARD_DEVIATION 238.2 • n=5 Participants	652.3 cells/µL STANDARD_DEVIATION 360.4 • n=7 Participants	545.4 cells/µL STANDARD_DEVIATION 280.2 • n=5 Participants	1122.9 cells/µL STANDARD_DEVIATION 537.1 • n=4 Participants	1647.5 cells/µL STANDARD_DEVIATION 965.7 • n=21 Participants	1359.6 cells/µL STANDARD_DEVIATION 1003.8 • n=10 Participants	744.3 cells/µL STANDARD_DEVIATION 654.9 • n=115 Participants
CD4 percentage	19.9 Percentage of total lymphocytes STANDARD_DEVIATION 9.6 • n=5 Participants	25.4 Percentage of total lymphocytes STANDARD_DEVIATION 8.2 • n=7 Participants	26.7 Percentage of total lymphocytes STANDARD_DEVIATION 10.6 • n=5 Participants	27.9 Percentage of total lymphocytes STANDARD_DEVIATION 8.2 • n=4 Participants	22.6 Percentage of total lymphocytes STANDARD_DEVIATION 8.1 • n=21 Participants	18.4 Percentage of total lymphocytes STANDARD_DEVIATION 11.5 • n=10 Participants	23 Percentage of total lymphocytes STANDARD_DEVIATION 9.9 • n=115 Participants
CDC HIV Clinical Classification A	17 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	5 participants n=4 Participants	6 participants n=21 Participants	4 participants n=10 Participants	33 participants n=115 Participants
CDC HIV Clinical Classification B	29 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	1 participants n=10 Participants	38 participants n=115 Participants
CDC HIV Clinical Classification C	24 participants n=5 Participants	7 participants n=7 Participants	2 participants n=5 Participants	8 participants n=4 Participants	3 participants n=21 Participants	0 participants n=10 Participants	41 participants n=115 Participants
CDC HIV Clinical Classification N	1 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants	7 participants n=4 Participants	3 participants n=21 Participants	7 participants n=10 Participants	14 participants n=115 Participants
Number of antiretroviral (ARV) classes previously used 0	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Number of antiretroviral (ARV) classes previously used 1	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	8 participants n=21 Participants	10 participants n=10 Participants	4 participants n=115 Participants
Number of antiretroviral (ARV) classes previously used 2	9 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	13 participants n=4 Participants	4 participants n=21 Participants	2 participants n=10 Participants	35 participants n=115 Participants
Number of antiretroviral (ARV) classes previously used ≥3	60 participants n=5 Participants	11 participants n=7 Participants	10 participants n=5 Participants	5 participants n=4 Participants	2 participants n=21 Participants	0 participants n=10 Participants	86 participants n=115 Participants
Duration of ARVs previously used	12 years STANDARD_DEVIATION 3.8 • n=5 Participants	8.5 years STANDARD_DEVIATION 2.3 • n=7 Participants	7.1 years STANDARD_DEVIATION 3 • n=5 Participants	2.4 years STANDARD_DEVIATION 1.4 • n=4 Participants	0.4 years STANDARD_DEVIATION 0.5 • n=21 Participants	0.1 years STANDARD_DEVIATION 0.1 • n=10 Participants	7.7 years STANDARD_DEVIATION 5.6 • n=115 Participants
Prior use of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) Yes	60 participants n=5 Participants	14 participants n=7 Participants	15 participants n=5 Participants	10 participants n=4 Participants	8 participants n=21 Participants	11 participants n=10 Participants	118 participants n=115 Participants
Prior use of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) No	11 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	11 participants n=4 Participants	6 participants n=21 Participants	1 participants n=10 Participants	34 participants n=115 Participants
Use of prior PIs Yes	69 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	13 participants n=4 Participants	5 participants n=21 Participants	0 participants n=10 Participants	113 participants n=115 Participants
Use of prior PIs No	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	8 participants n=4 Participants	9 participants n=21 Participants	12 participants n=10 Participants	39 participants n=115 Participants
Phenotypic Sensitivity score 0	5 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	6 participants n=115 Participants
Phenotypic Sensitivity score 1	15 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants	2 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	29 participants n=115 Participants
Phenotypic Sensitivity score 2	25 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants	8 participants n=4 Participants	2 participants n=21 Participants	5 participants n=10 Participants	50 participants n=115 Participants
Phenotypic Sensitivity score ≥3	21 participants n=5 Participants	7 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants	9 participants n=21 Participants	4 participants n=10 Participants	49 participants n=115 Participants
Phenotypic Sensitivity score Missing	5 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants	3 participants n=21 Participants	2 participants n=10 Participants	18 participants n=115 Participants
Genotypic sensitivity score 0	9 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	10 participants n=115 Participants
Genotypic sensitivity score 1	23 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants	2 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	39 participants n=115 Participants
Genotypic sensitivity score 2	20 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	11 participants n=4 Participants	3 participants n=21 Participants	5 participants n=10 Participants	52 participants n=115 Participants
Genotypic sensitivity score ≥3	18 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants	10 participants n=21 Participants	3 participants n=10 Participants	45 participants n=115 Participants
Genotypic sensitivity score Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	3 participants n=10 Participants	6 participants n=115 Participants

PRIMARY outcome

Timeframe: From study entry through Week 24

Population: Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.

Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)	20.3 percentage of participants Interval 11.0 to 32.8	25 percentage of participants Interval 0.6 to 80.6	15.4 percentage of participants Interval 1.9 to 45.4	30 percentage of participants Interval 11.9 to 54.3	35.7 percentage of participants Interval 12.8 to 64.9	33.3 percentage of participants Interval 9.9 to 65.1

PRIMARY outcome

Timeframe: From study entry through Week 24

The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From study entry through Week 24

Number of participants who died were summarized.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Number of Participants Who Died	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Population: Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule.

Outcome measures

Outcome measures
Measure	Cohort I n=11 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=11 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=10 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=12 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=8 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=11 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)	10.2 hour*mg/L Standard Deviation 10.0	13.4 hour*mg/L Standard Deviation 16.1	10.5 hour*mg/L Standard Deviation 3.5	9.5 hour*mg/L Standard Deviation 5.5	9.3 hour*mg/L Standard Deviation 3.2	10.9 hour*mg/L Standard Deviation 4.4

PRIMARY outcome

Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Population: Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Maximum plasma concentration (Cmax) was taken directly from the observed concentration-time data.

Outcome measures

Outcome measures
Measure	Cohort I n=11 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=11 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=10 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=12 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=8 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=11 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
PK Parameter: Maximum Plasma Concentration (Cmax)	2813.1 ng/mL Standard Deviation 2673.9	4055.7 ng/mL Standard Deviation 5269.5	5314.2 ng/mL Standard Deviation 2842.6	5204.8 ng/mL Standard Deviation 2940.6	5683.0 ng/mL Standard Deviation 3685.0	4299.0 ng/mL Standard Deviation 1661.9

PRIMARY outcome

Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Population: Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Time to half of maximum plasma concentration Cmax (T1/2) was taken directly from the observed concentration-time data.

Outcome measures

Outcome measures
Measure	Cohort I n=11 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=11 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=10 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=12 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=8 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=11 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)	4.9 hour Standard Deviation 3.6	3.7 hour Standard Deviation 1.4	4.5 hour Standard Deviation 4.2	4.1 hour Standard Deviation 3.2	3.0 hour Standard Deviation 1.8	2.1 hour Standard Deviation 1.5

PRIMARY outcome

Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Population: Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Plasma concentration at 12 hours postdose (C12h) was taken directly from the observed concentration-time data.

Outcome measures

Outcome measures
Measure	Cohort I n=11 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=11 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=10 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=12 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=8 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=11 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
PK Parameter: Concentration at 12 Hours Postdose (C12h)	197.0 ng/mL Standard Deviation 154.2	399.4 ng/mL Standard Deviation 880.9	78.7 ng/mL Standard Deviation 68.9	39.5 ng/mL Standard Deviation 21.9	56.4 ng/mL Standard Deviation 26.8	99.6 ng/mL Standard Deviation 83.9

SECONDARY outcome

Timeframe: From study entry through Week 48

Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)	23.7 percentage of participants Interval 13.6 to 36.6	25 percentage of participants Interval 0.6 to 80.6	23.1 percentage of participants Interval 5.0 to 53.8	40 percentage of participants Interval 19.1 to 63.9	42.9 percentage of participants Interval 17.7 to 71.1	33.3 percentage of participants Interval 9.9 to 65.1

SECONDARY outcome

Timeframe: From study entry through Week 48

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From study entry through Week 48

Number of participants who died were summarized.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Number of Participants Who Died	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 24, 48

Plasma HIV RNA concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular), and analyses used the Observed Failure Approach.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL Baseline to Week 24	72.4 percentage of participants Interval 59.1 to 83.3	50 percentage of participants Interval 6.8 to 93.2	76.9 percentage of participants Interval 46.2 to 95.0	70 percentage of participants Interval 45.7 to 88.1	85.7 percentage of participants Interval 57.2 to 98.2	100 percentage of participants Interval 71.5 to 100.0
Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL Baseline to Week 48	75 percentage of participants Interval 61.6 to 85.6	75 percentage of participants Interval 19.4 to 99.4	90.9 percentage of participants Interval 58.7 to 99.8	84.2 percentage of participants Interval 60.4 to 96.6	92.9 percentage of participants Interval 66.1 to 99.8	80 percentage of participants Interval 44.4 to 97.5

SECONDARY outcome

Timeframe: Baseline, Week 24, 48

Population: Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.

Change in CD4 cell count from baseline was calculated as the value at later visit minus the value at baseline.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Change of CD4 Count From Baseline Baseline to Week 24	114.6 cells/µL Interval 73.9 to 155.4	-35.8 cells/µL Interval -348.8 to 277.3	143.4 cells/µL Interval -12.9 to 299.6	147.2 cells/µL Interval -2.7 to 297.1	400.5 cells/µL Interval 60.3 to 740.6	499.2 cells/µL Interval -50.4 to 1048.7
Change of CD4 Count From Baseline Baseline to Week 48	168.4 cells/µL Interval 117.7 to 219.1	189.5 cells/µL Interval -154.2 to 533.2	76.8 cells/µL Interval -85.3 to 238.9	158.1 cells/µL Interval 11.7 to 304.4	278.8 cells/µL Interval -185.6 to 743.2	876.0 cells/µL Interval 362.7 to 1389.3

SECONDARY outcome

Timeframe: Baseline, Week 24, 48

Change in CD4 percent from baseline was calculated as the value of the later visit minus the value at baseline.

Outcome measures

Outcome measures
Measure	Cohort I n=59 Participants Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 Participants Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 Participants Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 Participants Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 Participants Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 Participants Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Change of CD4 Percent From Baseline Baseline to Week 24	4.1 percentage of total lymphocytes Interval 2.8 to 5.3	2.2 percentage of total lymphocytes Interval -7.2 to 11.5	0.8 percentage of total lymphocytes Interval -3.6 to 5.2	5.3 percentage of total lymphocytes Interval 2.9 to 7.7	6.2 percentage of total lymphocytes Interval 1.3 to 11.2	9.0 percentage of total lymphocytes Interval 4.6 to 13.4
Change of CD4 Percent From Baseline Baseline to Week 48	5.2 percentage of total lymphocytes Interval 3.9 to 6.6	6.0 percentage of total lymphocytes Interval -2.6 to 14.6	1.6 percentage of total lymphocytes Interval -2.7 to 5.9	4.3 percentage of total lymphocytes Interval 1.0 to 7.6	6.4 percentage of total lymphocytes Interval 1.4 to 11.3	8.7 percentage of total lymphocytes Interval 2.7 to 14.8

Adverse Events

Cohort I

Serious events: 26 serious events

Other events: 57 other events

Deaths: 0 deaths

Cohort IIA

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort IIB

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Cohort III

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort IV

Serious events: 7 serious events

Other events: 14 other events

Deaths: 1 deaths

Cohort V

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort I n=59 participants at risk Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 participants at risk Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 participants at risk Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 participants at risk Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 participants at risk Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 participants at risk Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Reproductive system and breast disorders Metrorrhagia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vaginal haemorrhage	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Asthma	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Anaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Haemolytic anaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Neutropenia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Thrombocytopenia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal pain	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Colitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Gastric fistula	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Gastritis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Oesophagitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Pancreatitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Adverse drug reaction	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Pyrexia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Hepatobiliary disorders Hyperbilirubinaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Abdominal abscess	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Acute sinusitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Appendicitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Gastroenteritis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Herpes zoster	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Lower respiratory tract infection	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Mastoiditis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Meningitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Mycobacterium avium complex infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Periorbital cellulitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumocystis jirovecii pneumonia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia bacterial	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia viral	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Respiratory tract infection viral	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Sepsis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Septic shock	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Varicella	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Varicella zoster virus infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Viral diarrhoea	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood alkaline phosphatase increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood bicarbonate decreased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood bilirubin increased	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Lipase abnormal	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Lipase increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Liver function test increased	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Neutrophil count decreased	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Transaminases increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Cachexia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Failure to thrive	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Metabolic acidosis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Pain in extremity	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Febrile convulsion	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Nystagmus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Seizure	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Pregnancy, puerperium and perinatal conditions Foetal death	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Pregnancy, puerperium and perinatal conditions Pregnancy	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Abnormal behaviour	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Depression	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Mental disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Suicidal behaviour	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Suicidal ideation	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Acute kidney injury	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash pruritic	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Social circumstances Treatment noncompliance	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Vascular disorders Hypovolaemic shock	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.

Other adverse events

Other adverse events
Measure	Cohort I n=59 participants at risk Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.	Cohort IIA n=4 participants at risk Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.	Cohort IIB n=13 participants at risk Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort III n=20 participants at risk Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of \~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.	Cohort IV n=14 participants at risk Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.	Cohort V n=12 participants at risk Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
Blood and lymphatic system disorders Anaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Haemolytic anaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Iron deficiency anaemia	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	28.6% 4/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Lymph node pain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Lymphadenitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Lymphadenopathy	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	35.0% 7/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	28.6% 4/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	41.7% 5/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Neutropenia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Pancytopenia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Blood and lymphatic system disorders Thrombocytopenia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Cardiac disorders Atrioventricular block first degree	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Cardiac disorders Congestive cardiomyopathy	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Cardiac disorders Left ventricular hypertrophy	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Cardiac disorders Palpitations	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Cardiac disorders Sinus bradycardia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Cardiac disorders Tachycardia	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Conductive deafness	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Deafness	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Ear canal erythema	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Ear congestion	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Ear discomfort	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Ear pain	23.7% 14/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.8% 4/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Ear pruritus	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Hypoacusis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Noninfective myringitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Otorrhoea	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Tinnitus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Tympanic membrane hyperaemia	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Ear and labyrinth disorders Tympanosclerosis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Conjunctival hyperaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Conjunctival pallor	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eye discharge	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eye irritation	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eye pain	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eye pruritus	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eye swelling	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eyelid oedema	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Eyelid thickening	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Keratitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Lacrimation increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Ocular hyperaemia	13.6% 8/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Periorbital oedema	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Photophobia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Eye disorders Vision blurred	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal distension	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal hernia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal mass	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal pain	20.3% 12/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	21.4% 3/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal pain lower	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal pain upper	13.6% 8/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Abdominal tenderness	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Anal pruritus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Anorectal discomfort	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Aphthous ulcer	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Breath odour	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Cheilitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Colitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Constipation	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Dental caries	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Diarrhoea	30.5% 18/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	35.0% 7/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	64.3% 9/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	58.3% 7/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Dysphagia	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Flatulence	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Food poisoning	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Gingival erythema	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Gingival pain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Infantile spitting up	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Infantile vomiting	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Inflammatory bowel disease	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Lip discolouration	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Lip ulceration	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Mouth ulceration	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Nausea	33.9% 20/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Oral discharge	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Oral disorder	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Oral mucosal blistering	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Oral mucosal erythema	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Rectal haemorrhage	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Stomatitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Toothache	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Gastrointestinal disorders Vomiting	35.6% 21/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.8% 4/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	45.0% 9/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	42.9% 6/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Adverse event	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Asthenia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Chest discomfort	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Chest pain	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Chills	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Crepitations	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Crying	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Cyst	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Fatigue	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Influenza like illness	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Local swelling	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Localised oedema	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Malaise	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Mass	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Nodule	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Non-cardiac chest pain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Oedema peripheral	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Pain	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Peripheral swelling	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Puncture site discharge	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Pyrexia	47.5% 28/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	75.0% 3/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	61.5% 8/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	45.0% 9/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	57.1% 8/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 6/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Secretion discharge	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
General disorders Tenderness	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Hepatobiliary disorders Hepatomegaly	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Hepatobiliary disorders Ocular icterus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Immune system disorders Anaphylactic reaction	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Immune system disorders Immune reconstitution inflammatory syndrome	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Abscess limb	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Acarodermatitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Acute sinusitis	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Bacterial sepsis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Bacterial vaginosis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Body tinea	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Bronchiolitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Bronchitis	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Candida infection	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Cellulitis	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Cervicitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Cervicitis human papilloma virus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Cervicitis trichomonal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Chlamydial cervicitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Chronic sinusitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Clostridium difficile colitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Conjunctivitis	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	20.0% 4/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Conjunctivitis bacterial	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Coxsackie viral infection	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Dysentery	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Epididymitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Escherichia urinary tract infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Fungal skin infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Gastroenteritis	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.0% 6/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	42.9% 6/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Gingivitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations H1N1 influenza	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations HIV associated nephropathy	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations HIV wasting syndrome	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Herpes simplex	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Herpes zoster	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Hymenolepiasis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Impetigo	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	45.0% 9/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Infection parasitic	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Influenza	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Laryngitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Latent tuberculosis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Lice infestation	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Meningitis bacterial	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Molluscum contagiosum	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Mycoplasma infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Oesophageal candidiasis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Onychomycosis	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Oral candidiasis	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Oral hairy leukoplakia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Oral herpes	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Orchitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Oropharyngeal candidiasis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Oropharyngeal gonococcal infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Otitis externa	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Otitis media	13.6% 8/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	45.0% 9/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	28.6% 4/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Otitis media acute	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Otitis media chronic	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pancreatitis viral	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Parotitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Persistent generalised lymphadenopathy	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pharyngeal chlamydia infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pharyngitis	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	42.9% 6/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	33.3% 4/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pharyngitis streptococcal	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumocystis jirovecii pneumonia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia bacterial	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia pneumococcal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pneumonia streptococcal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Proctitis chlamydial	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Proctitis gonococcal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Pulmonary tuberculosis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Purulent discharge	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Rash pustular	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Rhinitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Rubella	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Sinusitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Sinusitis bacterial	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 5/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Skin candida	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Skin infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Staphylococcal abscess	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Subcutaneous abscess	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tinea capitis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	20.0% 4/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tinea faciei	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tinea infection	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tinea pedis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tinea versicolour	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tonsillitis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	21.4% 3/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Tooth abscess	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Upper respiratory tract infection	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Urethritis chlamydial	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Urethritis gonococcal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Urinary tract infection	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Urinary tract infection bacterial	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Urinary tract infection staphylococcal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Vaginitis chlamydial	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Varicella	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Virologic failure	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Vulvovaginitis	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Infections and infestations Vulvovaginitis gonococcal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Ankle fracture	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Clavicle fracture	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Contusion	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Genital injury	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Hand fracture	8.5% 5/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Laceration	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Ligament sprain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Post procedural swelling	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Post-traumatic pain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Procedural pain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Skin abrasion	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Stoma site rash	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Injury, poisoning and procedural complications Wrist fracture	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Alanine aminotransferase increased	32.2% 19/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.8% 4/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	35.7% 5/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	33.3% 4/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Aspartate aminotransferase increased	25.4% 15/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.8% 4/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	20.0% 4/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	57.1% 8/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	33.3% 4/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood albumin decreased	20.3% 12/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	33.3% 4/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood alkaline phosphatase increased	18.6% 11/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood bicarbonate decreased	40.7% 24/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.8% 4/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	55.0% 11/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	57.1% 8/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	41.7% 5/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood bilirubin increased	22.0% 13/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	30.8% 4/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood calcium decreased	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood calcium increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood cholesterol increased	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	45.0% 9/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood creatinine increased	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood glucose decreased	37.3% 22/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	53.8% 7/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	40.0% 8/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	35.7% 5/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood glucose increased	23.7% 14/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	64.3% 9/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	33.3% 4/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood lactate dehydrogenase increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood lactic acid increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood magnesium decreased	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood pH increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood phosphorus decreased	23.7% 14/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	28.6% 4/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood potassium decreased	25.4% 15/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	35.7% 5/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood potassium increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	20.0% 4/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 7/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	75.0% 9/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood pressure decreased	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood pressure diastolic increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood pressure increased	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood pressure systolic increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood sodium abnormal	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood sodium decreased	47.5% 28/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	46.2% 6/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	70.0% 14/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	64.3% 9/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	83.3% 10/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood sodium increased	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood uric acid increased	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Blood urine present	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Breath sounds abnormal	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Electrocardiogram abnormal	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Gamma-glutamyltransferase abnormal	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Gamma-glutamyltransferase increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Haemoglobin decreased	13.6% 8/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	42.9% 6/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	75.0% 9/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Helicobacter test positive	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Lipase increased	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Low density lipoprotein increased	13.6% 8/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	40.0% 8/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Neutrophil count decreased	30.5% 18/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	38.5% 5/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	40.0% 8/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	78.6% 11/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Platelet count decreased	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Transaminases increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Viral load increased	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations Weight decreased	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	21.4% 3/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Investigations White blood cell count decreased	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Abnormal loss of weight	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Acidosis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Body fat disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Decreased appetite	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	28.6% 4/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Dehydration	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	21.4% 3/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Hyperlactacidaemia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Hyperlipidaemia	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Malnutrition	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Metabolic syndrome	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Metabolism and nutrition disorders Obesity	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Arthralgia	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Back pain	20.3% 12/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Costochondritis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Facial asymmetry	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Flank pain	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Head deformity	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Joint stiffness	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Joint swelling	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Kyphosis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Limb discomfort	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Muscle spasms	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Muscle twitching	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Myalgia	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Neck pain	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Pain in extremity	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Pain in jaw	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Musculoskeletal and connective tissue disorders Spinal pain	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Disturbance in attention	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Dizziness	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Dysarthria	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Dyscalculia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Dysgraphia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Dyslalia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Epilepsy	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Facial paralysis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Facial paresis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Headache	42.4% 25/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	100.0% 4/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Hyperreflexia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Hypersomnia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Hypertonia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Hypoaesthesia	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Language disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Meningeal disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Migraine	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Monoparesis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Muscle spasticity	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Neuropathy peripheral	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Paraesthesia	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Posterior reversible encephalopathy syndrome	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Psychomotor hyperactivity	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Seizure	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Speech disorder	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Syncope	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Thrombotic stroke	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Nervous system disorders Unresponsive to stimuli	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Pregnancy, puerperium and perinatal conditions First trimester pregnancy	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Pregnancy, puerperium and perinatal conditions Pregnancy	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Abnormal behaviour	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Adjustment disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Agitation	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Anger	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Anxiety	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Attention deficit/hyperactivity disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Depression	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Generalised anxiety disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Hallucination, auditory	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Initial insomnia	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Insomnia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Learning disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Major depression	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Mood swings	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Oppositional defiant disorder	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Reading disorder	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Restlessness	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Sexually inappropriate behaviour	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Psychiatric disorders Sleep terror	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Acute kidney injury	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Dysuria	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Haematuria	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Kidney enlargement	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Micturition urgency	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Pollakiuria	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Proteinuria	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Tubulointerstitial nephritis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Renal and urinary disorders Urine odour abnormal	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Breast tenderness	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Cervical dysplasia	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Dysmenorrhoea	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Male sexual dysfunction	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Perineal erythema	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Polycystic ovaries	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Testicular pain	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Testicular swelling	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Uterine haemorrhage	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vaginal discharge	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vaginal haemorrhage	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vaginal odour	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vaginal ulceration	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vulvovaginal discomfort	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vulvovaginal pruritus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Reproductive system and breast disorders Vulvovaginal rash	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Asthma	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Asthma exercise induced	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Cough	69.5% 41/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	46.2% 6/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	75.0% 15/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	64.3% 9/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	83.3% 10/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Nasal congestion	49.2% 29/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	53.8% 7/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	35.0% 7/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	42.9% 6/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	75.0% 9/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Nasal discharge discolouration	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Nasal oedema	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Nasal pruritus	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Nasal turbinate abnormality	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	42.4% 25/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	38.5% 5/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Oropharyngeal plaque	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pharyngeal exudate	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Productive cough	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Rales	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	6.8% 4/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	42.4% 25/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	46.2% 6/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	60.0% 12/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	42.9% 6/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	83.3% 10/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Rhonchi	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Sinus congestion	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Sinus pain	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Sneezing	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Tonsillar inflammation	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Use of accessory respiratory muscles	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Respiratory, thoracic and mediastinal disorders Wheezing	18.6% 11/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	23.1% 3/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	20.0% 4/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	21.4% 3/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Acne	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Alopecia	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Blister	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	21.4% 3/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Dry skin	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Eczema	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Erythema	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Macule	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	20.0% 4/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Nail discolouration	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Night sweats	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Pain of skin	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Papule	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Petechiae	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Photosensitivity reaction	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Pityriasis alba	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Pruritus	15.3% 9/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Pruritus generalised	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash	11.9% 7/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 2/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 5/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	50.0% 7/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	75.0% 9/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash generalised	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.4% 2/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	14.3% 2/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 3/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash macular	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Rash papular	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Scab	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	8.3% 1/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Skin discolouration	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Skin exfoliation	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Skin lesion	10.2% 6/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.1% 1/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	16.7% 2/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Skin plaque	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	15.0% 3/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Skin ulcer	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Swelling face	5.1% 3/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	7.7% 1/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Skin and subcutaneous tissue disorders Urticaria	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	10.0% 2/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Social circumstances Victim of sexual abuse	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	5.0% 1/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Vascular disorders Hypertension	0.00% 0/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	25.0% 1/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Vascular disorders Hypotension	3.4% 2/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.
Vascular disorders Pallor	1.7% 1/59 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/4 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/13 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/20 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/14 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.	0.00% 0/12 • From study entry to completion of the study at Week 240 or at 14 days after the premature study discontinuation. Adverse event summary pertains to the Final Dose Population: participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts werecombined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts. The study protocol required reporting of all new diagnoses, signs/symptoms, and laboratory events of \>=Grade 1; the protocol team assessed attribution to treatment for adverse events \>=Grade 3.

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Publication restrictions are in place

Restriction type: OTHER