Trial Outcomes & Findings for Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs (NCT NCT03896503)

Last Updated: 2025-09-19

Results Overview

The combination of M6620 with topotecan will be compared to topotecan alone in participants with relapsed small cell lung cancer (SCLC). Kaplan-Meier curves and a one-tailed log-rank test will be the primary analysis methods. PFS is defined as the duration of time from start of treatment to time of progression or death. whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and/or the appearance of one or more new lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

104 participants

Primary outcome timeframe

From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort.

Results posted on

2025-09-19

Participant Flow

104 participants were enrolled, and 82/104 participants were treated as shown in the Participant Flow table.

Participant milestones

Participant milestones
Measure	Platinum Response - Sensitive: Topotecan Monotherapy Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Enrolled But Not Treated Participants with pulmonary disease were enrolled but not treated.	Platinum Response - Resistant: Topotecan Monotherapy Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Enrolled But Not Treated Participants with pulmonary disease were enrolled but not treated.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Enrolled But Not Treated Participants were enrolled but not treated.
Initial Subgroup and Arm Enrollment STARTED	10	20	10	11	23	9	18	3
Initial Subgroup and Arm Enrollment Not Treated	1	0	10	1	2	9	2	3
Initial Subgroup and Arm Enrollment Off Treatment	7	17	0	10	0	0	16	0
Initial Subgroup and Arm Enrollment COMPLETED	7	18	0	10	20	0	16	0
Initial Subgroup and Arm Enrollment NOT COMPLETED	3	2	10	1	3	9	2	3
Crossover Participants STARTED	0	5	0	0	6	0	0	0
Crossover Participants Not Treated	0	0	0	0	0	0	0	0
Crossover Participants Off Treatment	0	0	0	0	0	0	0	0
Crossover Participants COMPLETED	0	5	0	0	6	0	0	0
Crossover Participants NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Platinum Response - Sensitive: Topotecan Monotherapy Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Enrolled But Not Treated Participants with pulmonary disease were enrolled but not treated.	Platinum Response - Resistant: Topotecan Monotherapy Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Enrolled But Not Treated Participants with pulmonary disease were enrolled but not treated.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Enrolled But Not Treated Participants were enrolled but not treated.
Initial Subgroup and Arm Enrollment Disease progression before treatment	1	0	1	0	1	0	0	0
Initial Subgroup and Arm Enrollment No treatment per protocol	0	0	1	0	0	1	0	0
Initial Subgroup and Arm Enrollment Late determination of ineligibility	0	0	1	0	0	1	0	1
Initial Subgroup and Arm Enrollment Declined to participate	0	0	1	1	1	1	0	0
Initial Subgroup and Arm Enrollment Not treated; participate found ineligible	0	0	0	0	0	2	0	0
Initial Subgroup and Arm Enrollment Not treated; screen failure	0	0	2	0	0	3	0	2
Initial Subgroup and Arm Enrollment Refused further treatment	2	1	0	0	0	0	0	0
Initial Subgroup and Arm Enrollment Off treatment? other reasons withdrew consent	0	1	0	0	0	0	0	0
Initial Subgroup and Arm Enrollment Not treated; death before treatment	0	0	0	0	1	0	0	0
Initial Subgroup and Arm Enrollment Off treatment; screen failure	0	0	0	0	0	1	1	0

Baseline Characteristics

Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=10 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Enrolled But Not Treated n=10 Participants Participants with pulmonary disease were enrolled but not treated.	Platinum Response - Resistant: Topotecan Monotherapy n=11 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=23 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Enrolled But Not Treated n=9 Participants Participants with pulmonary disease were enrolled but not treated.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=18 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Enrolled But Not Treated n=3 Participants Participants were enrolled but not treated.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	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	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants	6 Participants n=10 Participants	11 Participants n=115 Participants	1 Participants n=24 Participants	65 Participants n=42 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	2 Participants n=24 Participants	39 Participants n=42 Participants
Age, Continuous	56 years STANDARD_DEVIATION 9.53 • n=5 Participants	61.65 years STANDARD_DEVIATION 9.05 • n=7 Participants	63 years STANDARD_DEVIATION 8.17 • n=5 Participants	61.72 years STANDARD_DEVIATION 7.00 • n=4 Participants	60.60 years STANDARD_DEVIATION 7.57 • n=21 Participants	58.33 years STANDARD_DEVIATION 8.83 • n=10 Participants	57.94 years STANDARD_DEVIATION 13.24 • n=115 Participants	64.33 years STANDARD_DEVIATION 2.49 • n=24 Participants	60.16 years STANDARD_DEVIATION 9.48 • n=42 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants	3 Participants n=10 Participants	5 Participants n=115 Participants	0 Participants n=24 Participants	41 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants	6 Participants n=10 Participants	13 Participants n=115 Participants	3 Participants n=24 Participants	63 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	0 Participants n=24 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	20 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	22 Participants n=21 Participants	9 Participants n=10 Participants	18 Participants n=115 Participants	3 Participants n=24 Participants	103 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	0 Participants n=24 Participants	0 Participants n=42 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	2 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	3 Participants n=42 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	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=24 Participants	10 Participants n=42 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	20 Participants n=21 Participants	7 Participants n=10 Participants	14 Participants n=115 Participants	1 Participants n=24 Participants	88 Participants n=42 Participants
Race (NIH/OMB) More than one race	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	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Region of Enrollment United States	10 participants n=5 Participants	20 participants n=7 Participants	10 participants n=5 Participants	11 participants n=4 Participants	23 participants n=21 Participants	9 participants n=10 Participants	18 participants n=115 Participants	3 participants n=24 Participants	104 participants n=42 Participants

PRIMARY outcome

Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort.

Population: Participants enrolled but not treated are not reported for this outcome measure. Six participants from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment.

Outcome measures

Outcome measures
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Progression-free Survival (PFS) Reported With 80% Confidence Interval	5.5 Months Interval 2.6 to 6.0	4.4 Months Interval 3.4 to 5.5	2.1 Months Interval 1.3 to 3.0	2.7 Months Interval 2.0 to 4.0	1.5 Months Interval 1.4 to 1.8

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Progression-free Survival (PFS) Reported With 95% Confidence Interval	5.5 Months Interval 1.2 to 9.6	4.4 Months Interval 3.0 to 8.2	2.1 Months Interval 0.9 to 4.1	2.7 Months Interval 1.5 to 5.4	1.5 Months Interval 1.3 to 2.9

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants enrolled but not treated are not reported for this outcome measure. Ten participants from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment.

ORR is defined as percentage of participants who achieved either complete response (CR) or partial response (PR) as best response assessed using the revised Response Evaluation Criteria in Solid Tumors guideline (v 1.1). ORR percentage is calculated as the sum of the PR and CR rates, divided by the total number of participants who are evaluable for a response, multiplied by 100%. All participants included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions.

Outcome measures

Outcome measures
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=8 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=10 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=19 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=15 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Objective Response Rate (ORR) Complete Response	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0
Objective Response Rate (ORR) Partial Response	12.5 Percentage of participants Interval 0.3 to 52.7	35.0 Percentage of participants Interval 15.4 to 59.2	0 Percentage of participants Interval 0.0 to 30.9	15.8 Percentage of participants Interval 3.3 to 39.6	23.3 Percentage of participants Interval 1.7 to 40.5

SECONDARY outcome

Timeframe: Up to 2 years for pulmonary cohort and up 31.5 for Exploratory Cohort.

OS is defined as time from randomization to death, regardless of cause.

Outcome measures

Outcome measures
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Overall Survival (OS) Reported With 80% Confidence Interval	6.5 Months Interval 3.2 to 7.1	9.6 Months Interval 8.0 to 11.4	4.6 Months Interval 2.7 to 6.0	6.1 Months Interval 3.7 to 11.8	6.7 Months Interval 2.4 to 8.1

SECONDARY outcome

Timeframe: Up to 2 years for pulmonary cohort and up 31.5 for Exploratory Cohort

OS is defined as time from randomization to death, regardless of cause.

Outcome measures

Outcome measures
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Overall Survival (OS) Reported With 95% Confidence Interval	6.5 Months Interval 1.2 to 9.6	9.6 Months Interval 5.5 to 11.8	4.6 Months Interval 1.4 to 6.2	6.1 Months Interval 2.3 to 12.1	6.7 Months Interval 2.2 to 9.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, an average of 801.3 days.

Population: Participants enrolled but not treated are not reported for this outcome measure. Adverse events would not be monitored/assessed if the participant never received drug. Six participants (i.e., enrolled but not treated) from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 Participants Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 Participants Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 Participants Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	8 Participants	20 Participants	11 Participants	19 Participants	16 Participants

Adverse Events

Platinum Response - Sensitive: Topotecan Monotherapy

Serious events: 6 serious events

Other events: 8 other events

Deaths: 9 deaths

Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy

Serious events: 12 serious events

Other events: 20 other events

Deaths: 19 deaths

Platinum Response - Resistant: Topotecan Monotherapy

Serious events: 9 serious events

Other events: 11 other events

Deaths: 11 deaths

Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy

Serious events: 11 serious events

Other events: 19 other events

Deaths: 19 deaths

Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy

Serious events: 9 serious events

Other events: 16 other events

Deaths: 15 deaths

Platinum Response - Sensitive: Topotecan & M6620 Combination Therapy -Cross-over From Cohort 1 Arm I

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Platinum Response -Resistant: Topotecan & M6620 Combination Therapy - Cross-over From Cohort 2 Arm 1

Serious events: 4 serious events

Other events: 6 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 participants at risk Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 participants at risk Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 participants at risk Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 participants at risk Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 participants at risk Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 Combination Therapy -Cross-over From Cohort 1 Arm I n=5 participants at risk Platinum Response - Sensitive: Topotecan \& M6620 (VX-970) Combination Therapy -- Cross-over from Cohort 1 Arm I	Platinum Response -Resistant: Topotecan & M6620 Combination Therapy - Cross-over From Cohort 2 Arm 1 n=6 participants at risk Platinum Response - Resistant: Topotecan \& M6620 (VX-970) Combination Therapy -- Cross-over from Cohort 2 Arm 1
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Acidosis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Blood and lymphatic system disorders Anemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Anorexia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Cognitive disturbance	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Confusion	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Constipation	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Death NOS	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Depressed level of consciousness	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Disease progression	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Dysphasia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Edema face	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Fatigue	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders General disorders and administration site conditions - Other, death	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Hydrocephalus	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, Increased Lactic Acid	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Kidney infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Lung infection	55.6% 5/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Lymphocyte count decreased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Malaise	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Mobitz type I	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Multi-organ failure	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Brain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Nervous system disorders - Other, aphasia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Neutrophil count decreased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Pericardial tamponade	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Platelet count decreased	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Presyncope	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal calculi	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal colic	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Seizure	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Sepsis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Skin infection	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Stroke	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Thromboembolic event	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Urinary tract infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations White blood cell decreased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.

Other adverse events

Other adverse events
Measure	Platinum Response - Sensitive: Topotecan Monotherapy n=9 participants at risk Cohort I, Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy n=20 participants at risk Cohort I, Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan Monotherapy n=11 participants at risk Arm I (topotecan hydrochloride) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy n=20 participants at risk Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants with pulmonary disease receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy n=16 participants at risk Arm II (topotecan hydrochloride \& Berzosertib (M6620) Participants receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1-5 and Berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a computed tomography (CT) scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.	Platinum Response - Sensitive: Topotecan & M6620 Combination Therapy -Cross-over From Cohort 1 Arm I n=5 participants at risk Platinum Response - Sensitive: Topotecan \& M6620 (VX-970) Combination Therapy -- Cross-over from Cohort 1 Arm I	Platinum Response -Resistant: Topotecan & M6620 Combination Therapy - Cross-over From Cohort 2 Arm 1 n=6 participants at risk Platinum Response - Resistant: Topotecan \& M6620 (VX-970) Combination Therapy -- Cross-over from Cohort 2 Arm 1
Investigations Alanine aminotransferase increased	33.3% 3/9 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	30.0% 6/20 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	31.2% 5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Agitation	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Abdominal distension	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	43.8% 7/16 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Activated partial thromboplastin time prolonged	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Alkaline phosphatase increased	66.7% 6/9 • Number of events 13 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 10/20 • Number of events 15 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	80.0% 4/5 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Blood and lymphatic system disorders Anemia	88.9% 8/9 • Number of events 42 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	90.0% 18/20 • Number of events 80 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	81.8% 9/11 • Number of events 38 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	80.0% 16/20 • Number of events 81 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	75.0% 12/16 • Number of events 28 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	100.0% 5/5 • Number of events 33 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	83.3% 5/6 • Number of events 22 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Anorexia	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	35.0% 7/20 • Number of events 9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Anxiety	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Aspartate aminotransferase increased	33.3% 3/9 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Atelectasis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	43.8% 7/16 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Belching	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Bloating	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Leukopenia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Blood bicarbonate decreased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Blood bilirubin increased	22.2% 2/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Blood lactate dehydrogenase increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Eye disorders Blurred vision	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Bronchial infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Injury, poisoning and procedural complications Bruising	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Injury, poisoning and procedural complications Burn	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Cardiac troponin T increased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Eye disorders Cataract	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Chest pain - cardiac	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Chills	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Chronic kidney disease	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Cognitive disturbance	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Confusion	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Conjunctivitis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Constipation	44.4% 4/9 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 8/20 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Cough	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Creatinine increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	31.2% 5/16 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Dehydration	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Delirium	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Depression	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	45.5% 5/11 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	36.4% 4/11 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Dry mouth	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Dysarthria	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Dysgeusia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Dysphagia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Dyspnea	44.4% 4/9 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	45.5% 5/11 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	66.7% 4/6 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Dysuria	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Ear and labyrinth disorders Ear pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Edema face	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Edema limbs	44.4% 4/9 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	36.4% 4/11 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Electrocardiogram T wave abnormal	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Encephalopathy	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Rectal pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Esophagitis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Eye disorders Eye disorders - Other, R Eye Issue	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Eye infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Facial muscle weakness	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Injury, poisoning and procedural complications Fall	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Fatigue	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	65.0% 13/20 • Number of events 24 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	81.8% 9/11 • Number of events 20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	55.0% 11/20 • Number of events 18 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	62.5% 10/16 • Number of events 15 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	66.7% 4/6 • Number of events 9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Fever	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Flatulence	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Flu like symptoms	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Flushing	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Injury, poisoning and procedural complications Fracture	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Gait disturbance	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Gastrointestinal disorders - Other, Cold sores on tongue	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders General disorders and administration site conditions - Other, Aches	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders General disorders and administration site conditions - Other, Specify	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders General disorders and administration site conditions - Other, catheter occulsion	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Generalized edema	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Glucosuria	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Hallucinations	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	35.0% 7/20 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Heart failure	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Hematuria	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Hepatobiliary disorders Hepatic failure	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Herpes simplex reactivation	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Hot flashes	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypercalcemia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyperglycemia	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	30.0% 6/20 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	31.2% 5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypermagnesemia	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypernatremia	22.2% 2/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyperphosphatemia	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	36.4% 4/11 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 3/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Hypertension	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypoalbuminemia	55.6% 5/9 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	45.5% 5/11 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 4/16 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypocalcemia	33.3% 3/9 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	30.0% 6/20 • Number of events 16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	63.6% 7/11 • Number of events 14 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	37.5% 6/16 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	66.7% 4/6 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypokalemia	55.6% 5/9 • Number of events 15 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 13 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	35.0% 7/20 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 13 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypomagnesemia	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	35.0% 7/20 • Number of events 17 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	36.4% 4/11 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hyponatremia	33.3% 3/9 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	45.0% 9/20 • Number of events 36 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	35.0% 7/20 • Number of events 16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	43.8% 7/16 • Number of events 9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	31.2% 5/16 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Hypotension	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	35.0% 7/20 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Hypoxia	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations INR increased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Injection site reaction	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Insomnia	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, CK elevated	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, Increased ANC	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, Increased PT	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, Increased WBC	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, LDH elevate	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, d.bili increased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Investigations - Other, lightheadedness	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Irritability	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Lethargy	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Lipase increased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Localized edema	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Lung infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Lymphocyte count decreased	55.6% 5/9 • Number of events 25 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	75.0% 15/20 • Number of events 41 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	72.7% 8/11 • Number of events 33 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	55.0% 11/20 • Number of events 25 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	62.5% 10/16 • Number of events 22 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 19 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 3/6 • Number of events 16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Lymphocyte count increased	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Malaise	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Memory impairment	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, Lactic Acid	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Mucositis oral	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Muscle cramp	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, RT shoulder stiffness	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Nail discoloration	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Nausea	44.4% 4/9 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	45.0% 9/20 • Number of events 18 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 10/20 • Number of events 16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	37.5% 6/16 • Number of events 10 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	83.3% 5/6 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, skin cancer	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Nervous system disorders - Other, numbness	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Nervous system disorders - Other, aphasia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Neutrophil count decreased	44.4% 4/9 • Number of events 8 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 10/20 • Number of events 16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	54.5% 6/11 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	55.0% 11/20 • Number of events 15 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	56.2% 9/16 • Number of events 12 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	50.0% 3/6 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Oral pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Ear and labyrinth disorders Otitis externa	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
General disorders Pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Musculoskeletal and connective tissue disorders Pain in extremity	44.4% 4/9 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Palpitations	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Pancreatitis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Papulopustular rash	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Paresthesia	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Reproductive system and breast disorders Pelvic pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Personality change	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Platelet count decreased	77.8% 7/9 • Number of events 35 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	100.0% 20/20 • Number of events 71 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	100.0% 11/11 • Number of events 37 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	80.0% 16/20 • Number of events 67 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	87.5% 14/16 • Number of events 37 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	80.0% 4/5 • Number of events 29 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	100.0% 6/6 • Number of events 17 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Pneumonitis	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Pneumothorax	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Presyncope	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Proteinuria	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal and urinary disorders - Other, Catheter occlusion	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal and urinary disorders - Other, Difficulty urinating	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal and urinary disorders - Other, decreased urine output	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal calculi	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Renal colic	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Specify	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Intermittent warm sensation	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Pulmonary vascular congestion	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, chest-shortness of breath w/exertion	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Psychiatric disorders Restlessness	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Seizure	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Sepsis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Sinus bradycardia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Sinus tachycardia	22.2% 2/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.8% 3/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	40.0% 2/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Bee Stings	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Blister	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Cellulitis	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Cellulitis-Rt Eyebrow	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Dermatitis rash	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Rash NOS on bilateral arms	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Rash NOS on lower back	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Scalp Sensitivty	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Skin Lesions	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, candidal intertrigo	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, jaundice	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, port scab	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, skin irritation	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, sunburn	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, suprapubic erythema	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Skin infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Skin and subcutaneous tissue disorders Skin ulceration	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Somnolence	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Superficial thrombophlebitis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Cardiac disorders Supraventricular tachycardia	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Reproductive system and breast disorders Testicular pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Thromboembolic event	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Thrush	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Toothache	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Transient ischemic attacks	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Nervous system disorders Tremor	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Upper respiratory infection	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Urinary frequency	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Urinary incontinence	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Urinary retention	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Infections and infestations Urinary tract infection	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Urinary tract pain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Renal and urinary disorders Urine discoloration	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Vascular disorders Vascular disorders - Other, pulmonary embolus	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Ear and labyrinth disorders Vertigo	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	9.1% 1/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Gastrointestinal disorders Vomiting	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	25.0% 5/20 • Number of events 6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	30.0% 6/20 • Number of events 13 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Weight gain	0.00% 0/9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/20 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/5 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations Weight loss	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 4/20 • Number of events 7 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Respiratory, thoracic and mediastinal disorders Wheezing	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/11 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/16 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	0.00% 0/6 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.
Investigations White blood cell decreased	66.7% 6/9 • Number of events 14 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	70.0% 14/20 • Number of events 28 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	63.6% 7/11 • Number of events 26 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 12/20 • Number of events 22 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	68.8% 11/16 • Number of events 22 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	60.0% 3/5 • Number of events 9 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.	66.7% 4/6 • Number of events 14 • Date treatment consent signed to date off study, an average of 801.3 days. Adverse events would not be monitored/assessed if the participant never received drug (i.e., enrolled but not treated). This is not a cross over study, rather there is an option to cross over, and exploratory data collected. 11 participants crossed over. Adverse events for cross over participants are represented in initial arm, and separately in the table below.

Additional Information

Dr. Anish Thomas

National Cancer Institute

Phone: 240-760-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60